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Author: Julio Martinez-Clark

  • Medical Device Risk Classification in Latin America: 2026 Guide

    PRACTICAL GUIDE | 2026

    Get the class and grouping right before you build the dossier.

    By Julio G. Martinez-Clark

    CEO, bioaccess®

    Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.

    The short version

    Risk classification is not a label you carry from the United States or Europe into Latin America. It is a country-specific regulatory decision that determines the registration route, grouping architecture, supporting evidence, fees, timing, and even which products can share one filing. Make that decision before translation and dossier assembly—not after an agency asks you to split the application.

    Classification derails filings before the dossier does

    When a medical-device registration stalls in Latin America, the instinct is to blame the dossier: a missing certificate, a bad translation, or an incomplete technical file. In practice, the more expensive mistake often happens earlier. The product was classified or grouped incorrectly before the dossier was built.

    bioaccess® recently developed a Colombia-and-Peru registration strategy for a US electrosurgery manufacturer's full device line. The portfolio included generators, monopolar and bipolar instruments, reusable and single-use variants, neutral plates, cables, footswitches, and a factory kit. The hard question was not whether the documents existed. It was which products could legally share a registration—and why.

    That distinction matters. A classification error can change the application type, evidence requirements, grouping logic, government fees, review clock, and number of registrations. If the error is found after filing, the sponsor may face an agency requirement, a forced split, or an entirely new submission.

    Rule No. 1

    Do not assume a US Food and Drug Administration product code or a European Union Medical Device Regulation class maps one-to-one onto a Latin American class. Each authority applies its own rules, definitions, intended-use analysis, and grouping criteria.

    The country map: similar class numbers, different consequences

    Use this as an orientation map, not as a substitute for a device-specific classification memo. The intended purpose, duration of use, invasiveness, active function, anatomy, and combination with other products can change the outcome.

    Market Risk classes Core basis What changes
    Colombia — INVIMA I, IIa, IIb, III Decreto 4725/2005, as amended I and IIa: automatic registration. IIb and III: full technical evaluation.
    Peru — DIGEMID I, II, III, IV D.S. 016-2011-SA, as amended; Ley 29459 Low, moderate, high and critical risk. Approved family composition governs future additions.
    Brazil — ANVISA I, II, III, IV RDC 751/2022 I and II: notificação. III and IV: registro.
    Mexico — COFEPRIS I, II, III RIS, Art. 83; LGS, Art. 262 Check the low-risk no-registration list and available equivalence routes.
    Argentina — ANMAT I, II, III, IV Disposición 2318/02 (TO 2004), as amended Confirm the procedural dispositions in force at filing.
    Chile — ISP I, II, III, IV Decreto Supremo 825/1998 Historically, mandatory registration has applied only to a listed subset. Confirm transition status.

    Colombia: classification changes the procedure, not just the label

    Decreto 4725 de 2005, as amended, establishes Classes I, IIa, IIb, and III in Article 5. Article 7 contains the 18 classification rules. Article 6 sets the implementing principles: intended purpose governs; products used in combination are classified separately; accessories are classified separately from the parent device; software that drives a device takes that device's class; and when several rules apply, the strictest rule governs.

    The commercial consequence is immediate. Class I and IIa registrations proceed under Colombia's automatic-registration regime. Class IIb and III products receive a full technical evaluation. If the class is wrong, the sponsor has selected the wrong procedure—not merely the wrong box on a form.

    Grouping requires equal care. Article 28 permits several devices to share a sanitary registration when they have the same risk classification, use, and generic denomination, and it addresses systems and kits used together. Under INVIMA's current grouping circulars—including Circular 5000-0001-22 and Circular 500-3052-16, subject to confirmation that they remain in force—exclusive parts, accessories, consumables, and spare parts may sometimes be covered by the parent equipment's registration. Factory kits must be assessed under the rules for kits and systems, with the highest-risk component governing classification.

    Peru: the approved family defines what you can add later

    Peru uses four classes under D.S. 016-2011-SA, as amended and issued under Ley 29459: Class I (low risk), Class II (moderate risk), Class III (high risk), and Class IV (critical risk).

    Do not treat family composition as flexible after approval. The approved registration defines the family's scope. Adding products that fall outside that scope generally requires a new registration or a formal modification that DIGEMID may reject. The practical rule is simple: decide the family architecture before filing, and document why every model belongs.

    Brazil: the current rule is RDC 751/2022

    Brazil retains Classes I through IV under ANVISA RDC 751/2022, in force since March 2023. Classes I and II proceed through notificação; Classes III and IV require registro. RDC 185/2001 is revoked and should not be used as the operative legal basis. A classification error therefore changes the regulatory pathway.

    Mexico: check the low-risk list before building a registration

    Mexico uses Classes I, II, and III under Article 83 of the Reglamento de Insumos para la Salud; the medical-device definition appears in Article 262 of the Ley General de Salud. COFEPRIS also publishes an Acuerdo listing certain low-risk products that do not require sanitary registration. Missing that list can waste a full registration effort. Mexico also provides an equivalence route for qualifying devices with United States Food and Drug Administration or Health Canada approval; confirm eligibility for the exact product and current procedure.

    Argentina and Chile: confirm the procedural regime in force

    Argentina uses Classes I through IV under ANMAT Disposición 2318/02 (texto ordenado 2004), as amended. Confirm the procedural dispositions and submission route that are current when the filing starts.

    Chile recognizes Classes I through IV under Decreto Supremo 825/1998, but historically mandatory Instituto de Salud Pública registration has applied only to a listed subset of medical devices. Do not describe Chile as a comprehensive mandatory-registration market without checking the current list. Chile is moving toward a broader medical-device law, so sponsors must confirm the transition status immediately before acting.

    Scope carve-outs

    This guide addresses general medical devices. In Colombia, in vitro diagnostic devices are governed separately by Decreto 3770 de 2004; Brazil also regulates IVDs under a separate RDC. Software as a medical device follows specialized rules and should receive its own classification analysis.

    Five mistakes that create preventable delay

    1. Treating FDA or EU classification as portable

    A 510(k) letter, FDA product code, or EU Medical Device Regulation certificate is evidence. It is not a Latin American classification decision. Start with the intended purpose and the local rules in each country. Then use the foreign authorization to support—not replace—the local analysis.

    The same warning applies to grouping. A set of models organized as one European technical-file "family" is not automatically one INVIMA family, one DIGEMID family, or one ANVISA notification. The legal tests are different.

    2. Mixing risk classes inside an ordinary family

    In the electrosurgery project, the manufacturer's first instinct was to group Class I neutral plates with Class IIb active electrodes in one monopolar family. That may look logical from a catalog perspective. It is not an ordinary family under Colombia's Article 28, which requires the same risk classification for ordinary grouping.

    Filing Class I and IIb products as one ordinary family creates a predictable risk: an INVIMA request or a forced split. A defensible alternative may be to place exclusive accessories and consumables under the generator's registration, using the equipment-with-exclusive-accessories route in INVIMA's current grouping rules. When accepted, those accessories can be imported and marketed under the equipment's registration number. The factual record must show that the accessories were designed and approved for use with that equipment.

    3. Hiding a multi-function kit inside a device family

    A factory kit can combine products that do not share one function or class. In the real project, a blepharoplasty kit included monopolar and bipolar instruments, neutral plates, and cables. That commercial reference could not simply ride inside the monopolar family.

    If the manufacturer wants to market the kit as a named, factory-established reference, assess it as a kit or system under Colombia's Article 28 and the applicable INVIMA grouping circulars. A separate registration may be required. The highest-risk component governs classification—a principle also reflected in the approaches used in Brazil and Argentina. Do not assume that bundling products in one box makes them one device.

    4. Splitting variants automatically—or grouping them without evidence

    In Colombia, sterile versus non-sterile, or single-use versus reusable, variants of the same device do not automatically require separate registrations when intended purpose, generic denomination, and risk classification remain compatible. The distinction still needs technical support through labeling, sterilization or reprocessing validation, shelf life, and the instructions for use.

    Do not export that conclusion to every market. In other countries, these variants can affect grouping, evidence requirements, and, under some rule sets, classification itself. Run the local analysis.

    5. Letting the documents contradict the strategy

    A sound classification can still fail if the source documents disagree. Before filing, reconcile the Certificate to Foreign Government or Certificate of Free Sale, CE certificate, instructions for use, labels, technical files, and declarations of conformity. The names, models, intended uses, indications, sterility status, reusability, and claimed class must match the filing architecture.

    Legalization, apostille, and validity-period problems for CFS/CFG and ISO 13485 certificates generate agency questions just as often as content inconsistencies. Check both substance and formal validity.

    In the electrosurgery project, a reissued CE certificate added devices and changed the filing scope. But a model newer than the current CFG could not enter the submission merely because it appeared on the CE certificate. Those stock-keeping units became fileable only when the supporting market-authorization certificate was reissued to include them. One updated document does not cure a mismatch across the set.

    Before you file: a classification and consistency check

    Complete this review before translation, legalization, pricing, or submission. If any answer is uncertain, stop and resolve it before the dossier hardens around the wrong strategy.

    • Freeze the intended purpose. Use one approved statement across the IFU, labels, certificates, technical file, and application.
    • Classify country by country. Document the local rule, the facts that trigger it, and why stricter competing rules do or do not apply.
    • Classify accessories separately. Then determine whether exclusive accessories qualify to sit under the equipment registration.
    • Build a model-level matrix. List every catalog number, generic name, intended use, class, sterility, reusability, and proposed registration.
    • Test every family. Confirm the models meet the local tests for class, use, generic denomination, design, and presentation.
    • Test every kit. List each component and class; identify the highest-risk component; decide whether the named kit requires a separate registration.
    • Reconcile every source document. Match product names, models, indications, class, sterility, and reusability across the CFG/CFS, CE certificate, IFUs, labels, technical files, and declarations.
    • Check formal validity. Confirm issuer, validity period, legalization or apostille, and required translations for the CFS/CFG and ISO 13485 certificate.
    • Verify the current procedure. Confirm that the law, agency circulars, low-risk lists, equivalence routes, and transition rules are still in force on filing day.
    • Write the rationale. Keep a short classification-and-grouping memorandum in the submission file so the strategy can survive agency scrutiny and later portfolio additions.

    The operating principle

    Classification first. Grouping second. Document reconciliation third. Translation and filing come after all three are stable. Reversing that order turns a regulatory judgment into expensive rework.

    Build the registration architecture before the agency does it for you

    bioaccess® helps medical-device companies classify, group, and register portfolios across Latin America. Our Medical Device Registration & Market Access team supports ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, and DIGEMID strategies—from the first model matrix and document-gap review through local representation, submission, and post-market requirements.

    If your portfolio includes multiple models, accessories, kits, sterile and reusable variants, or certificates that do not line up perfectly, resolve the architecture before filing. A short strategy review now is cheaper than a forced split later.

    Talk with bioaccess® about your Latin America registration strategy

    Regulatory references

    • Colombia: Decreto 4725 de 2005, as amended; Decreto 3770 de 2004 for in vitro diagnostics; applicable INVIMA grouping circulars, including 5000-0001-22 and 500-3052-16, subject to confirmation that they remain in force.
    • Peru: Ley 29459; Decreto Supremo 016-2011-SA, as amended.
    • Brazil: ANVISA RDC 751/2022 for general medical devices; separate regulation applies to in vitro diagnostics.
    • Mexico: Ley General de Salud, Article 262; Reglamento de Insumos para la Salud, Article 83; current COFEPRIS low-risk Acuerdo and equivalence procedures.
    • Argentina: ANMAT Disposición 2318/02 (texto ordenado 2004), as amended, together with current procedural dispositions.
    • Chile: Decreto Supremo 825/1998; current Instituto de Salud Pública mandatory-registration list and medical-device-law transition materials.

    Last verified: September 2026

    This guide is general information only and does not constitute legal or regulatory advice. Agency rules, circulars, lists, and procedures change frequently; confirm your strategy with qualified regulatory counsel before relying on it. Mike provides decision-support and is not a licensed attorney.

  • Class II Medical Device: FDA Rules Every Sponsor Must Know

    Class II Medical Device: FDA Rules Every Sponsor Must Know

    Medical device classification sits at the center of every regulatory strategy, and class II is where most sponsors land — and where the rules carry the most nuance. Class II covers an unusually wide range of device types, from blood pressure monitors to orthopedic implants, and the regulatory requirements attached to that classification shape your entire path to market and, critically, your clinical evidence strategy.

    This article breaks down what class II means under FDA rules, how the 510(k) pathway works, where clinical data becomes necessary, and what sponsors need to understand before committing to a trial strategy.

    What Makes a Device Class II

    FDA classifies medical devices into three classes based on the level of control needed to provide reasonable assurance of safety and effectiveness. Class I carries the lowest risk. Class III carries the highest. Class II sits in the middle — and that middle ground is where the regulatory complexity lives.

    A class II device is one for which general controls alone (labeling, manufacturing standards, registration) are insufficient to provide that assurance, but for which enough existing scientific and clinical knowledge exists to establish special controls. Special controls include performance standards, post-market surveillance requirements, guidance documents, and clinical data requirements that vary by device type.

    FDA assigns every device a product code and a regulation number under 21 CFR Parts 862 through 892. That regulation number tells you the device type, the classification, and the applicable special controls. If your device doesn't have a predicate in an existing product code, you may need to petition FDA to create one — a process that adds time and cost before you've submitted anything.

    The 510(k) Pathway: Core Mechanics

    Most class II devices reach the US market through a 510(k) premarket notification. The 510(k) is not an approval — it is a clearance. You are not proving your device is safe and effective in absolute terms. You are demonstrating substantial equivalence to a legally marketed predicate device.

    Substantial equivalence requires showing that your device has the same intended use as the predicate and either the same technological characteristics, or different technological characteristics that don't raise new questions of safety and effectiveness and perform at least as well as the predicate.

    Three types of 510(k) submissions exist:

    • Traditional 510(k): The standard route. Full summary of safety and effectiveness data, comparison to predicate, and supporting bench, animal, and clinical data where required.
    • Abbreviated 510(k): Used when FDA has issued a special controls guidance document for the device type. You demonstrate compliance with that guidance rather than building a full predicate comparison from scratch.
    • Special 510(k): Used for modifications to your own legally cleared device. Relies on design controls and risk analysis to demonstrate the modification doesn't affect safety or effectiveness.

    FDA's target review time for a standard 510(k) is 90 days. In practice, the clock stops whenever FDA issues an Additional Information (AI) request — which means real-world timelines frequently extend to 6 to 12 months or longer, depending on submission complexity and the number of AI cycles.

    When Clinical Data Is Required for Class II

    This is the question most sponsors underestimate. The assumption that class II devices don't need clinical data is wrong. Whether clinical data is required depends on the device type, the predicate, the technological differences, and the special controls applicable to your product code.

    FDA's guidance on 510(k) content makes clear that clinical data may be needed when bench and animal testing can't adequately characterize performance in the intended use environment, when the device interacts with the human body in ways that require in vivo evidence, or when the special controls for your device type specifically call for clinical performance data.

    For implantable class II devices, active devices with direct patient contact, or devices where the predicate comparison involves performance claims that can only be validated clinically, a clinical study is not optional. It is a submission requirement.

    This is where the clinical strategy decision becomes consequential. If your 510(k) will require a clinical dataset, you face the same planning questions as any sponsor preparing for a first-in-human study: where to run the study, how long it will take, what the per-patient cost looks like, and whether the resulting data will satisfy FDA's review criteria.

    Class II vs. Class III: Where the Line Falls

    Understanding what separates class II from class III matters because some devices start as class III candidates and work toward reclassification, while others are developed with the intent to pursue a De Novo pathway to establish a new class II category.

    Class III devices require Premarket Approval (PMA) — the most demanding regulatory pathway FDA operates. PMA requires valid scientific evidence, typically from well-controlled clinical investigations, demonstrating reasonable assurance of safety and effectiveness. The evidentiary bar is substantially higher than 510(k), and the timeline is correspondingly longer.

    A device that lacks a predicate and doesn't fit neatly into an existing class I or class II product code is automatically class III by default. The De Novo pathway allows sponsors to petition FDA to reclassify such a device into class I or class II by establishing new special controls. A successful De Novo creates a new product code, and the approved device then becomes a predicate that other sponsors can reference.

    For sponsors at the pre-clinical or IDE-ready stage, knowing whether your device is genuinely class II eligible — or whether it will require De Novo or PMA — determines the entire regulatory timeline and capital requirement.

    Special Controls and What They Actually Require

    Special controls are the mechanism FDA uses to manage class II risk. They are not uniform. Each product code carries its own set, and those controls define the evidence you need to generate.

    Common special controls include:

    • Performance testing standards (mechanical, electrical, biocompatibility per ISO 10993)
    • Software validation requirements under 21 CFR 820 and FDA's Software as a Medical Device (SaMD) guidance
    • Labeling requirements specifying contraindications, warnings, and instructions for use
    • Post-market surveillance obligations under 21 CFR 822
    • Clinical performance data requirements specifying study design, endpoints, and patient population

    When a device's special controls include clinical performance data, the study design must satisfy those requirements precisely. An underpowered study, a poorly defined primary endpoint, or a patient population that doesn't match the intended use will generate an AI request — or a Not Substantially Equivalent (NSE) determination.

    Getting the study design right before you start enrolling patients is not a detail. It is the foundational work that determines whether your clinical investment produces a usable 510(k) dataset.

    The IDE Question for Class II Studies

    If your class II device requires a clinical study and poses more than minimal risk, you may need an Investigational Device Exemption (IDE) before that study can begin in the United States. Under 21 CFR Part 812, a significant risk (SR) device study requires an approved IDE from FDA before enrollment begins.

    Non-significant risk (NSR) studies don't require a formal IDE application to FDA, but they do require Institutional Review Board (IRB) approval and must comply with abbreviated IDE requirements.

    The SR/NSR determination is made by the IRB in the first instance, but FDA's guidance makes clear that sponsors should conduct their own SR/NSR assessment and be prepared to defend it. Getting this wrong — treating an SR device as NSR — creates compliance exposure that can invalidate the data.

    For sponsors who want to generate clinical evidence before committing to a US IDE, running a first-in-human study outside the United States is a legitimate and well-established strategy. Foreign clinical data is accepted for US IDE and IND submissions under FDA 21 CFR 812.28, provided the data is collected under conditions comparable to US standards and the study design meets FDA's requirements. Acceptance is not automatic — it depends on study design and data quality.

    Class II Clinical Strategy: The LATAM Acceleration Option

    For class II device sponsors who need clinical evidence to support a 510(k) or build toward an IDE, running that study in Latin America offers a materially different cost and timeline profile than the US or EU.

    Ethics and regulatory approvals in Panama, El Salvador, Chile, and the Dominican Republic are observed in 30 to 90 days — compared to 6 to 12 months in the US or EU. Per-patient costs in Panama range from $12,000 to $22,000. For a sponsor working within a $1 million to $5 million clinical budget with an investor milestone tied to a specific date, those numbers change what is achievable within a single funding cycle.

    The Cook Group's multi-site first-in-human study of an artificial venous valve, run across Colombia with more than 142 INVIMA regulatory submissions managed, is one example of how complex class II-adjacent device programs have been executed in the region with full regulatory rigor. The Cook Group case study on the bioaccess® site details the operational and regulatory mechanics of that program.

    Envveno Medical's path to the first-ever FDA IDE for a non-surgical replacement venous valve illustrates how a LATAM first-in-human foundation translates directly into a US regulatory submission — exactly the bridge that class II sponsors with clinical data requirements need to understand.

    The key requirement is that the study is designed to FDA standards from the start. Data collected under ISO 14155 protocol architecture and structured per FDA 21 CFR 812.28 can support a US submission. Data collected without that design discipline cannot.

    510(k) Submission: What FDA Reviews

    A complete 510(k) submission includes a defined set of elements. Understanding what FDA reviewers look for helps sponsors build the right evidence package from the beginning rather than retrofitting data after an AI request.

    FDA reviews:

    • Device description: Intended use, indications for use, technological characteristics
    • Predicate comparison: Substantial equivalence argument with side-by-side feature comparison
    • Performance testing summary: Bench, animal, and clinical data supporting safety and effectiveness claims
    • Biocompatibility: ISO 10993 testing appropriate to the device's nature of contact and duration
    • Software documentation: If applicable, per FDA's Software as a Medical Device guidance
    • Labeling: Draft labeling consistent with the intended use and special controls
    • Sterilization and shelf life: If applicable
    • Clinical data: When required by special controls or the nature of the predicate comparison

    The most common reasons for AI requests are incomplete performance testing, inadequate predicate comparison, missing or insufficient clinical data, and labeling that doesn't match the intended use. Each AI cycle adds months to the review clock.

    De Novo: Creating a New Class II Category

    When a novel device lacks a predicate and the sponsor believes class II controls are sufficient to manage the risk, the De Novo pathway is the route to market. A successful De Novo results in a new product code, a classification order, and a legally marketed device that other sponsors can use as a predicate.

    The De Novo process requires demonstrating that general controls and special controls together provide reasonable assurance of safety and effectiveness. FDA reviews the proposed special controls as part of that process. For genuinely novel devices, the evidentiary requirements sit closer to PMA than to a standard 510(k).

    De Novo timelines are longer than 510(k) — FDA's target is 150 days, but complex submissions take longer. Sponsors pursuing De Novo need to plan for a clinical evidence package that supports the proposed special controls, which often means a well-designed first-in-human or early feasibility study.

    The ClarVista Medical case study — a LATAM first-in-human program that ultimately led to an Alcon acquisition — illustrates how early-stage clinical execution in Latin America can support the kind of evidence package that moves a novel ophthalmic device through the US regulatory process.

    Post-Market Requirements for Class II Devices

    Clearance is not the end of the regulatory relationship with FDA. Class II devices carry post-market obligations that sponsors need to plan for before they reach market.

    Medical Device Reporting (MDR) under 21 CFR Part 803 requires manufacturers to report device malfunctions, serious injuries, and deaths to FDA. Reporting timelines are strict: 30 days for most events, 5 days for events requiring remedial action to prevent unreasonable risk.

    Post-market surveillance under 21 CFR Part 822 may be ordered by FDA for class II devices when the agency determines that post-market data is needed to protect public health. This is more common for implantable devices and devices with novel technologies.

    Quality System Regulation (QSR) under 21 CFR Part 820 — now transitioning to alignment with ISO 13485 — applies to all class II manufacturers. Design controls, corrective and preventive action (CAPA), complaint handling, and production and process controls are all auditable.

    Sponsors who treat regulatory compliance as a pre-market activity only will encounter problems. Building quality system infrastructure in parallel with clinical development is the standard FDA expects.

    Preparing for a Pre-Sub Meeting

    Before committing to a 510(k) strategy, most class II sponsors benefit from a Pre-Submission (Pre-Sub) meeting with FDA. A Pre-Sub is a formal mechanism to get FDA's feedback on your regulatory approach, your proposed predicate, your study design, and your performance testing plan before you invest in generating the data.

    FDA responds to Pre-Sub requests in writing within 90 days. The response is not binding, but it provides a documented basis for your development decisions. If FDA identifies a problem with your predicate selection or proposed clinical study design in a Pre-Sub response, you can address it before spending the budget — not after.

    For sponsors considering a LATAM clinical study to generate 510(k) or IDE-supporting data, the Pre-Sub is the right place to confirm that FDA will accept foreign clinical data for your specific submission and to agree on study design requirements in advance.

    Practical Checklist for Class II Sponsors

    Before finalizing your regulatory strategy, confirm the following:

    • Your device's product code and regulation number under 21 CFR Parts 862–892
    • The applicable special controls for your product code and whether they require clinical data
    • Whether a predicate device exists and whether it supports a substantial equivalence argument
    • Whether your study, if required, qualifies as SR or NSR under IDE rules
    • Whether a Pre-Sub meeting would de-risk your predicate or study design decisions
    • Whether your clinical budget and timeline are compatible with a US-based study or whether a LATAM execution strategy better fits your financial runway

    For device types where LATAM execution is appropriate, the Hasten/Ampcare case study demonstrates how the COFEPRIS-04-050 abbreviated pathway in Mexico was used to register a TENS device — a practical example of how Latin American regulatory infrastructure can serve device sponsors at different stages of their commercial strategy.

    Frequently Asked Questions

    What is a class II medical device under FDA rules?
    A class II medical device is one for which general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, but for which special controls — such as performance standards, post-market surveillance, and clinical data requirements — can provide that assurance. Most class II devices reach the US market through a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate.

    Does a class II device always need clinical data for a 510(k)?
    Not always, but more often than sponsors expect. Whether clinical data is required depends on the device type, the applicable special controls, and the nature of the predicate comparison. Implantable devices, active devices with direct patient contact, and devices where performance claims can only be validated in vivo typically require clinical data as part of the 510(k) submission.

    What is the difference between a 510(k) and a De Novo for class II?
    A 510(k) relies on substantial equivalence to an existing predicate device. A De Novo is used when a novel device lacks a predicate and the sponsor wants to establish a new class II product code. A successful De Novo creates a new predicate that other sponsors can reference. De Novo requires more evidence than a standard 510(k) and takes longer to review.

    Can clinical data from Latin America support a US 510(k) or IDE submission?
    Yes. Under FDA 21 CFR 812.28, foreign clinical data is accepted for US IDE and IND submissions when collected under conditions comparable to US standards. The study must be designed to FDA requirements from the start — including ISO 14155 protocol architecture and appropriate GCP compliance. FDA acceptance depends on study design and data quality and is not automatic.

    When does a class II study require an IDE?
    A clinical study involving a class II device that poses significant risk requires an approved IDE from FDA before enrollment begins in the United States. Non-significant risk studies require IRB approval and compliance with abbreviated IDE requirements but do not require a formal FDA IDE application. The SR/NSR determination should be made carefully — misclassifying an SR device as NSR creates compliance exposure.

    What are special controls and why do they matter for class II sponsors?
    Special controls are device-type-specific requirements FDA uses to manage class II risk. They vary by product code and can include performance testing standards, biocompatibility requirements, software validation, labeling requirements, post-market surveillance obligations, and clinical data requirements. Understanding the special controls for your specific product code is essential before you design your evidence generation strategy.

    How long does a 510(k) review take?
    FDA's target review time for a standard 510(k) is 90 days, but the clock stops during any Additional Information request period. In practice, complex submissions with clinical data requirements or multiple AI cycles frequently take 6 to 12 months from submission to clearance. A Pre-Sub meeting before submission can reduce AI cycles by resolving predicate and study design questions in advance.

    Build the Right Evidence Package from the Start

    Class II regulation is not a single rule — it is a framework that varies significantly by device type, predicate, and the specific special controls attached to your product code. The sponsors who move through the 510(k) process efficiently are the ones who understand those specifics before they start generating data, not after.

    If your class II device requires clinical evidence and your timeline can't absorb a 12-to-18-month US study startup, understanding your LATAM options is a practical next step. bioaccess® works with device sponsors at the pre-clinical to IDE-ready stage to design and execute first-in-human and early feasibility studies structured for FDA submission. Learn more at bioaccessla.com.

  • Hcor São Paulo: The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hcor São Paulo as a bioaccess® client.

    If you searched Hcor Sao Paulo first-in-human, Hospital do Coracao Sao Paulo clinical trial, Hcor CRO, or “go direct Hcor São Paulo,” you followed a campus string ClinicalTrials.gov still publishes. Hcor in São Paulo, Brazil, is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named São Paulo Hcor campus. It is DISTINCT from other live São Paulo campuses (Hospital São Paulo UNIFESP, Instituto do Coração HCFMUSP, Medcin, Beneficência Portuguesa — do not near-dup collapse Beneficência). Sharing São Paulo metro is not a license to collapse them. Hcor is not InCor HCFMUSP. Hcor is not Beneficência Portuguesa. Hcor is not Hospital São Paulo UNIFESP.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Hcor (São Paulo, Brazil) — canonical NCT string: ALL interventional n=17; DEVICE n=1. Example NCT IDs: NCT05398497.

    Cite canonical ALL n=17 and DEVICE n=1. Do not clone InCor HCFMUSP, Beneficência Portuguesa, or Hospital São Paulo UNIFESP onto this slug.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.

    That is the leak: a founder searching Hcor São Paulo first-in-human finds ALL n=17 (DEVICE n=1) without finding ANVISA. A named hospital campus is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the hospital can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the hospital is not built to own for an investigational device:

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Hcor is not an InCor HCFMUSP file and is not a Beneficência Portuguesa file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANVISA actually works (the short version)

    Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

    Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    Hcor São Paulo is a serious named Brazilian campus on the public registry. ALL n=17 and DEVICE n=1 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Hcor São Paulo directly for a device FIH?

    You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Instituto do Coração HCFMUSP or Beneficência Portuguesa?

    No. instituto-coracao-hcfmusp-fih is already live. Beneficência Portuguesa São Paulo is already live — do not near-dup merge. This page is Hcor only.

    Did bioaccess® run NCT05398497?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. São Paulo sibling (do not merge): Instituto do Coração HCFMUSP.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Federal University of Bahia Salvador: The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Federal University of Bahia Salvador as a bioaccess® client.

    If you searched Federal University of Bahia Salvador first-in-human, UFBA clinical trial, Universidade Federal da Bahia CRO, or “go direct Federal University of Bahia Salvador,” you followed a campus string ClinicalTrials.gov still publishes. Federal University of Bahia (UFBA) in Salvador, Brazil, is a real named university-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: the university is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the university still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Salvador UFBA campus (alias includes Hospital Universitário Professor Edgard Santos / HUPES-UFBA). It is DISTINCT from live idor-regional-bahia-salvador-fih and nucleo-oncologia-bahia-salvador-fih. Sharing Salvador / Bahia is not a license to collapse them. UFBA is not IDOR Regional Bahia. UFBA is not Núcleo de Oncologia da Bahia.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Federal University of Bahia (Salvador, Brazil) — canonical NCT string: ALL interventional n=18; DEVICE n=3. Example NCT IDs: NCT01968512, NCT02152267, NCT07633444.

    Cite canonical ALL n=18 and DEVICE n=3. Do not clone IDOR Regional Bahia or Núcleo de Oncologia da Bahia onto this slug.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this university as a client site.

    That is the leak: a founder searching Federal University of Bahia Salvador first-in-human finds ALL n=18 (DEVICE n=3) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named university can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the university can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the university is not built to own for an investigational device:

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UFBA is not an IDOR Regional Bahia file and is not a Núcleo de Oncologia da Bahia file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANVISA actually works (the short version)

    Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

    Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    Federal University of Bahia Salvador is a serious named Brazilian campus on the public registry. ALL n=18 and DEVICE n=3 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Federal University of Bahia Salvador directly for a device FIH?

    You can try. The university can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this university. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as IDOR Regional Bahia or Núcleo de Oncologia da Bahia Salvador?

    No. idor-regional-bahia-salvador-fih and nucleo-oncologia-bahia-salvador-fih are already live. This page is Federal University of Bahia Salvador only.

    Did bioaccess® run NCT01968512?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Salvador sibling (do not merge): IDOR Regional Bahia Salvador.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • IADT Buenos Aires: The NCT Campus String Is Not the ANMAT File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANMAT, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim IADT Buenos Aires as a bioaccess® client.

    If you searched IADT Buenos Aires first-in-human, IADT Argentina clinical trial, IADT CRO, or “go direct IADT Buenos Aires,” you followed a campus string ClinicalTrials.gov still publishes. IADT in Buenos Aires, Argentina, is a real named institute/center string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

    bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns ANMAT, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the institute still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Buenos Aires IADT campus. It is DISTINCT from live Psoriahue (CMS 96118), IDIM (CMS 96119), Centro Medico Arsema (batch 55), and FLENI Buenos Aires. Sharing Buenos Aires / Argentina is not a license to collapse them. IADT is not Psoriahue. IADT is not IDIM. IADT is not FLENI.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • IADT (Buenos Aires, Argentina) — canonical NCT string: ALL interventional n=19; DEVICE n=1. Example NCT IDs: NCT04061733.

    Cite canonical ALL n=19 and DEVICE n=1. Do not clone Psoriahue, IDIM, Arsema, or FLENI onto this slug.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this institute as a client site.

    That is the leak: a founder searching IADT Buenos Aires first-in-human finds ALL n=19 (DEVICE n=1) without finding ANMAT. A named institute is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named institute can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the institute can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the institute is not built to own for an investigational device:

    • ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at IADT is not a Psoriahue file, not an IDIM file, and not a FLENI file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANMAT actually works (the short version)

    Use live bioaccess® Argentina / ANMAT pages for the full pathway. Trial authorization and commercial registro are different petitions. Do not put both on one Gantt labeled “Argentina.” A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs; ask for a protocol-specific calendar rather than treating an NCT row as start-up.

    Ask for a protocol-specific calendar. A hospital email is not ANMAT clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    IADT is a serious named Buenos Aires campus on the public registry. ALL n=19 and DEVICE n=1 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANMAT / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract IADT Buenos Aires directly for a device FIH?

    You can try. The institute can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANMAT applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this institute. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Psoriahue, IDIM, or FLENI Buenos Aires?

    No. Psoriahue is CMS 96118. IDIM is CMS 96119. FLENI Buenos Aires is already live from batch 56. This page is IADT only.

    Did bioaccess® run NCT04061733?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. CABA sibling (do not merge): FLENI Buenos Aires.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Fundacion Oftalmologica De Santander: The NCT Campus String Is Not the INVIMA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current INVIMA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Fundacion Oftalmologica De Santander as a bioaccess® client.

    If you searched Fundacion Oftalmologica De Santander first-in-human, FOSCAL clinical trial, Fundacion Oftalmologica Santander CRO, or “go direct Fundacion Oftalmologica De Santander,” you followed a campus string ClinicalTrials.gov still publishes. Fundacion Oftalmologica De Santander in Santander, Colombia, is a real named foundation-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the INVIMA file.

    bioaccess®’s position is simple and it is not adversarial: the foundation is the site. The First-in-Human CRO still owns INVIMA, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the foundation still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Santander Fundacion Oftalmologica De Santander campus. It is not Fundación CTIC Bogotá, not Fundación Reumatología Fernando Chalem Bogotá, and not a Bogotá merge. Sharing a Fundación name is not a license to collapse them. Fundacion Oftalmologica De Santander is not CTIC. Fundacion Oftalmologica De Santander is not Fernando Chalem.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Fundacion Oftalmologica De Santander (Santander, Colombia) — canonical NCT string: ALL interventional n=20; DEVICE n=1. Example NCT IDs: NCT05883943.

    Cite canonical ALL n=20 and DEVICE n=1. Do not clone CTIC or Fernando Chalem onto this slug. Colombia NEW-FIH public line stays unchanged (leftover_lib COLOMBIA_P).

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this foundation as a client site.

    That is the leak: a founder searching Fundacion Oftalmologica De Santander first-in-human finds ALL n=20 (DEVICE n=1) without finding INVIMA. A named foundation is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named foundation can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the foundation can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the foundation is not built to own for an investigational device:

    • INVIMA. INVIMA is the national file for an investigational device in Colombia. Resolución 8430/1993 still sits on the ethics and research side of that stack. A hallway conversation on this campus is not the INVIMA dossier. Resolución 2378 does not govern device clinical trials — see the live country pages rather than importing a drug-GCP resolution onto a device file. A hallway conversation at Fundacion Oftalmologica De Santander is not a CTIC Bogotá file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How INVIMA actually works (the short version)

    Use CRO in Colombia. Published comparison already on the Panama country page: Colombia ethics typically 4–6 weeks; per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country. We pick the country the device needs. A hospital email in Montería is not INVIMA clearance.

    Ask for a protocol-specific calendar. A hospital email is not INVIMA clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    Fundacion Oftalmologica De Santander is a serious named Colombian campus on the public registry. ALL n=20 and DEVICE n=1 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator. Colombia NEW-FIH recommendation stays unchanged.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the INVIMA / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Fundacion Oftalmologica De Santander directly for a device FIH?

    You can try. The foundation can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your INVIMA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this foundation. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Fundación CTIC Bogotá?

    No. fundacion-ctic-bogota-fih is already live. This page is Fundacion Oftalmologica De Santander only.

    Did bioaccess® run NCT05883943?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Colombia sibling (do not merge): Fundación CTIC Bogotá.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Universidade Federal Fluminense Niterói: The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Universidade Federal Fluminense Niterói as a bioaccess® client.

    If you searched Universidade Federal Fluminense Niteroi first-in-human, UFF Niteroi clinical trial, Universidade Federal Fluminense CRO, or “go direct Universidade Federal Fluminense Niterói,” you followed a campus string ClinicalTrials.gov still publishes. Universidade Federal Fluminense in Niterói, Brazil, is a real named university-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: the university is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the university still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Niterói UFF campus. It is DISTINCT from live universidade-federal-fluminense-nova-friburgo-fih (Nova Friburgo — different city) and from complexo-hospitalar-niteroi-fih. Sharing UFF / Niterói is not a license to collapse them. UFF Niterói is not UFF Nova Friburgo. UFF Niterói is not Complexo Hospitalar Niterói.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Universidade Federal Fluminense (Niterói, Brazil) — canonical NCT string: ALL interventional n=21; DEVICE n=3. Example NCT IDs: NCT03687047, NCT04512677, NCT06967649.

    Cite canonical ALL n=21 and DEVICE n=3. Do not clone Nova Friburgo UFF or Complexo Hospitalar Niterói onto this slug.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this university as a client site.

    That is the leak: a founder searching Universidade Federal Fluminense Niterói first-in-human finds ALL n=21 (DEVICE n=3) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named university can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the university can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the university is not built to own for an investigational device:

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UFF Niterói is not a Nova Friburgo file and is not a Complexo Hospitalar Niterói file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANVISA actually works (the short version)

    Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

    Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    Universidade Federal Fluminense Niterói is a serious named Brazilian campus on the public registry. ALL n=21 and DEVICE n=3 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Universidade Federal Fluminense Niterói directly for a device FIH?

    You can try. The university can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this university. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as UFF Nova Friburgo or Complexo Hospitalar Niterói?

    No. universidade-federal-fluminense-nova-friburgo-fih and complexo-hospitalar-niteroi-fih are already live. This page is Universidade Federal Fluminense Niterói only.

    Did bioaccess® run NCT03687047?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Distinct sibling (do not merge): Universidade Federal Fluminense Nova Friburgo.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Federal University of Santa Maria: The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Federal University of Santa Maria as a bioaccess® client.

    If you searched Federal University of Santa Maria first-in-human, UFSM clinical trial, Universidade Federal de Santa Maria CRO, or “go direct Federal University of Santa Maria,” you followed a campus string ClinicalTrials.gov still publishes. Federal University of Santa Maria (UFSM) in Santa Maria, Brazil, is a real named university-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: the university is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the university still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Santa Maria UFSM campus (Brazil). It is DISTINCT from live clinica-santa-maria-santiago-fih (Chile — different country, different regulator). It is not Hospital de Clínicas Porto Alegre / HCPA and not Federal University of São Carlos. Sharing a Santa Maria name is not a license to collapse Chile and Brazil. UFSM is not Clínica Santa María Santiago. UFSM is not HCPA.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Federal University of Santa Maria (Santa Maria, Brazil) — canonical NCT string: ALL interventional n=25; DEVICE n=5. Example NCT IDs: NCT02088138, NCT02600182, NCT03154970.

    Cite canonical ALL n=25 and DEVICE n=5. Do not clone Clínica Santa María Santiago or HCPA onto this slug. Example device NCT IDs use the first 3 of the device list; full device list remains in the backlog.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this university as a client site.

    That is the leak: a founder searching Federal University of Santa Maria first-in-human finds ALL n=25 (DEVICE n=5) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named university can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the university can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the university is not built to own for an investigational device:

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UFSM Santa Maria Brazil is not a Clínica Santa María Santiago Chile file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANVISA actually works (the short version)

    Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

    Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    Federal University of Santa Maria is a serious named Brazilian campus on the public registry. ALL n=25 and DEVICE n=5 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Federal University of Santa Maria directly for a device FIH?

    You can try. The university can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this university. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Clínica Santa María Santiago?

    No. clinica-santa-maria-santiago-fih is the Chile campus under ISP. This page is Federal University of Santa Maria (Brazil / ANVISA) only.

    Did bioaccess® run NCT02088138?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Distinct Chile sibling (do not merge): Clínica Santa María Santiago.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • São Paulo State University São José dos Campos: The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim São Paulo State University São José dos Campos as a bioaccess® client.

    If you searched Sao Paulo State University Sao Jose dos Campos first-in-human, UNESP Sao Jose dos Campos clinical trial, Sao Paulo State University CRO, or “go direct São Paulo State University São José dos Campos,” you followed a campus string ClinicalTrials.gov still publishes. São Paulo State University in São José dos Campos, Brazil, is a real named university-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: the university is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the university still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named São José dos Campos São Paulo State University (UNESP) campus. It is DISTINCT from live unesp-faculdade-medicina-botucatu-fih (Botucatu — different city). It is not university-of-sao-paulo-fih, not universidade-federal-de-sao-paulo-fih (UNIFESP), and not Medcin Instituto da Pele São Paulo. Sharing a São Paulo State / UNESP name is not a license to collapse Botucatu and São José dos Campos. UNESP São José dos Campos is not UNESP Botucatu. UNESP São José dos Campos is not USP.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • São Paulo State University (São José dos Campos, Brazil) — canonical NCT string: ALL interventional n=27; DEVICE n=2. Example NCT IDs: NCT05916716, NCT05916742.

    Cite canonical ALL n=27 and DEVICE n=2. Do not clone Botucatu UNESP, USP, or UNIFESP onto this slug.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this university as a client site.

    That is the leak: a founder searching São Paulo State University São José dos Campos first-in-human finds ALL n=27 (DEVICE n=2) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named university can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the university can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the university is not built to own for an investigational device:

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UNESP São José dos Campos is not a Botucatu Faculdade de Medicina file and is not a USP file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANVISA actually works (the short version)

    Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

    Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    São Paulo State University São José dos Campos is a serious named Brazilian campus on the public registry. ALL n=27 and DEVICE n=2 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract São Paulo State University São José dos Campos directly for a device FIH?

    You can try. The university can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this university. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as UNESP Faculdade de Medicina Botucatu?

    No. unesp-faculdade-medicina-botucatu-fih is already live for the Botucatu campus. This page is São Paulo State University São José dos Campos only — different city.

    Did bioaccess® run NCT05916716?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Distinct Botucatu sibling (do not merge): UNESP Faculdade de Medicina Botucatu.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Clínica Universitaria Colombia Bogotá: The NCT Campus String Is Not the INVIMA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current INVIMA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Clínica Universitaria Colombia Bogotá as a bioaccess® client.

    If you searched Clinica Universitaria Colombia Bogota first-in-human, Clinica Universitaria Colombia clinical trial, Clinica Universitaria Colombia CRO, or “go direct Clínica Universitaria Colombia Bogotá,” you followed a campus string ClinicalTrials.gov still publishes. Clínica Universitaria Colombia in Bogotá, Colombia, is a real named hospital/clinic-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the INVIMA file.

    bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns INVIMA, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Bogotá Clínica Universitaria Colombia campus. It is not Fundación CTIC Bogotá, not Fundación Reumatología Fernando Chalem Bogotá, and not a generic Bogotá hospital fold. Sharing Bogotá is not a license to collapse them. Clínica Universitaria Colombia is not CTIC. Clínica Universitaria Colombia is not Fernando Chalem.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Clínica Universitaria Colombia (Bogotá, Colombia) — canonical NCT string: ALL interventional n=28; DEVICE n=1. Example NCT IDs: NCT06735547.

    Cite canonical ALL n=28 and DEVICE n=1. Do not clone CTIC or Fernando Chalem onto this slug. Colombia NEW-FIH public line stays unchanged (leftover_lib COLOMBIA_P).

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.

    That is the leak: a founder searching Clínica Universitaria Colombia Bogotá first-in-human finds ALL n=28 (DEVICE n=1) without finding INVIMA. A named hospital/clinic campus is still a site. An NCT location row is not a CRO.

    The site is the site. The CRO is the operator.

    A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the hospital can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the hospital is not built to own for an investigational device:

    • INVIMA. INVIMA is the national file for an investigational device in Colombia. Resolución 8430/1993 still sits on the ethics and research side of that stack. A hallway conversation on this campus is not the INVIMA dossier. Resolución 2378 does not govern device clinical trials — see the live country pages rather than importing a drug-GCP resolution onto a device file. A hallway conversation at Clínica Universitaria Colombia is not a CTIC file and is not a Fernando Chalem file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How INVIMA actually works (the short version)

    Use CRO in Colombia. Published comparison already on the Panama country page: Colombia ethics typically 4–6 weeks; per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country. We pick the country the device needs. A hospital email in Montería is not INVIMA clearance.

    Ask for a protocol-specific calendar. A hospital email is not INVIMA clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    Clínica Universitaria Colombia is a serious named Bogotá campus on the public registry. ALL n=28 and DEVICE n=1 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator. Colombia NEW-FIH recommendation stays unchanged.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the INVIMA / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Clínica Universitaria Colombia Bogotá directly for a device FIH?

    You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your INVIMA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Fundación CTIC Bogotá?

    No. fundacion-ctic-bogota-fih is already live. This page is Clínica Universitaria Colombia Bogotá only.

    Did bioaccess® run NCT06735547?

    No. We cite it as facility evidence. We will not invent a sponsor or a PI.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Bogotá sibling (do not merge): Fundación CTIC Bogotá.

    Julio G. Martinez-Clark, CEO · bioaccess®