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  • Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start

    Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start

    This guide has been merged into our updated hub, Clinical Trial Liability Insurance in Latin America: Requirements by Country, which sets out each country’s rule with links to the primary legal text (verified 29 October 2026).

  • First-in-Human Trial Timeline: From Protocol Approval to Last Patient Out

    First-in-Human Trial Timeline: From Protocol Approval to Last Patient Out

    A first-in-human (FIH) trial is one of the most consequential milestones in any medical device or biopharma program — and one of the most consistently misread from a timing standpoint. Founders anchor investor timelines to a vague "18 to 24 months," then discover mid-program that the approval queue alone consumed most of that window before a single patient was screened.

    This article maps the actual phases of a first-in-human trial timeline, from protocol approval through last patient out (LPO). It covers where time is lost, where it can be recovered, and which structural decisions made early determine whether your FIH data lands before or after your next funding round.

    What “Protocol Approval” Actually Means as a Starting Point

    The phrase sounds like a single event. In practice, it represents the convergence of several parallel workstreams: a finalized protocol document, an approved IDE or IND application, ethics committee clearance, and written authorization from the relevant in-country health authority.

    Each of those has its own queue. In the United States, IDE review alone typically takes three to six months after submission. Ethics review at U.S. sites often adds another two to four months — and sites may not run those processes concurrently. By the time you have a protocol approved and a site ready to screen patients, you may already be nine to twelve months into your clock.

    This is why jurisdiction selection is not a logistical detail. It is a timeline decision.

    Phase 1: Regulatory and Ethics Approvals

    This phase begins the moment your submission package is filed with the relevant health authority and ethics committee. It ends when you have written authorization to proceed at a qualified site.

    In the United States, this phase routinely takes six to twelve months. Review queues are long, and novel device classes often generate multiple rounds of questions and amendments before authorization is granted.

    In Panama, El Salvador, Chile, and the Dominican Republic, ethics and regulatory approvals are observed in 30 to 90 days. That is not a marketing claim — it reflects the structural design of those jurisdictions' review frameworks. MINSA/CNBI in Panama, SRS/CNEIS in El Salvador, ISP/MINSAL in Chile, and the Dominican Republic's equivalent health authority all operate under processes that are faster by design, not by exception.

    Recovering four to nine months at this phase alone changes the math for a startup operating on a 24-month runway.

    Phase 2: Site Activation

    Site activation covers everything between regulatory authorization and the first patient screened: finalizing site agreements, training investigators and coordinators, confirming equipment and logistics, and standing up your electronic data capture (EDC) system at the site.

    At a well-prepared site with an experienced coordinator team, this phase takes four to eight weeks. At a site that has never run a device trial under ISO 14155 or FDA 21 CFR 812.28 standards, it can stretch to three to four months.

    This is where a pre-qualified site network pays a measurable dividend. Sites that have already been verified for infrastructure, staffing, and regulatory familiarity compress activation to the shorter end of that range. bioaccess® maintains a network of 50-plus pre-qualified sites across 19 Latin American and Caribbean markets — which means you are not rebuilding site readiness from scratch every time you open a new location.

    Site activation also includes the practical work of setting up patient identification and screening pipelines. Enrollment projections made without a realistic assessment of site-level recruitment capacity are one of the most common sources of timeline slippage.

    Phase 3: Patient Enrollment

    Enrollment is where most FIH timelines diverge from plan. The variables are well known — inclusion/exclusion criteria, site-level patient flow, competing trials, screen failure rates — but they are still routinely underestimated.

    For a small FIH cohort of 10 to 30 patients, enrollment at a single site in a high-competition U.S. market can take six to twelve months. In Latin American markets with lower trial density and strong investigator engagement, the same cohort often enrolls in two to four months.

    A few factors that materially affect enrollment speed:

    • Indication prevalence at the site. A cardiovascular device trial at a high-volume cardiac center in Panama or Colombia will screen faster than the same trial at a community hospital with limited patient throughput.
    • Screen failure rate. For novel device classes with narrow eligibility criteria, screen failure rates of 40 to 60 percent are common. Building that into your enrollment model upfront prevents mid-trial surprises.
    • Regulatory flexibility on amendments. If your protocol requires a mid-enrollment amendment — a common occurrence in early feasibility studies — the time to get that amendment approved varies significantly by jurisdiction.

    Phase 4: Treatment and Follow-Up

    For most FIH device studies, the treatment period itself is relatively short — days to weeks per patient. The follow-up period is where the timeline stretches. Depending on device class and endpoint structure, follow-up windows of 30 days, 90 days, six months, or longer are common.

    Last patient out is defined as the date the final enrolled patient completes their last protocol-required visit. Everything before that point — enrollment, treatment, interim assessments — determines when LPO actually occurs.

    The relationship between enrollment pace and LPO is direct. Enroll your last patient at month eight of a study with a 90-day follow-up, and LPO lands at month eleven. Let enrollment drag to month twelve, and LPO moves to month fifteen. This is why front-end enrollment compression has compounding value: it pulls LPO forward and accelerates the entire downstream data and submission timeline.

    Phase 5: Data Lock and Submission-Ready Package

    After LPO, the trial is not over. Data cleaning, query resolution, statistical analysis, and clinical study report (CSR) preparation typically take two to four months for a small FIH study — and six months or more for larger or more complex programs.

    This phase is often treated as a formality in early planning conversations, but it is where regulatory acceptability is either confirmed or complicated. Data collected under ICH-GCP and structured per FDA 21 CFR 812.28 — the foreign clinical data framework — is accepted for U.S. IDE and IND submissions. Data collected under looser standards may not be.

    That distinction matters specifically for Latin American FIH data. The speed advantage of running a trial in Panama or Chile does not come at the cost of regulatory acceptability, provided the data is collected under the right framework from day one. A submission-ready clinical evidence package built to FDA standards travels with the data regardless of where the patients were enrolled.

    What a Realistic End-to-End Timeline Looks Like

    Putting the phases together, here is what a realistic FIH timeline from protocol approval to submission-ready package looks like:

    Phase Optimized (LatAm) Typical (U.S./EU)
    Regulatory and ethics approvals 1 to 3 months 6 to 12 months
    Site activation 1 to 2 months 2 to 4 months
    Patient enrollment (10 to 30 patients) 2 to 4 months 6 to 12 months
    Treatment and follow-up 1 to 6 months 1 to 6 months
    Data lock and CSR 2 to 3 months 3 to 6 months
    Total 7 to 18 months 18 to 40 months

    The treatment and follow-up window is largely fixed by the science, not the geography. Everything else is compressible with the right jurisdiction and site infrastructure.

    Where Startups Lose Time — and How to Avoid It

    The most damaging sources of FIH timeline slippage are rarely the obvious ones.

    Delayed regulatory strategy alignment. Sponsors who select a jurisdiction or site before finalizing their IDE or IND strategy often have to redo submission documents when the regulatory pathway shifts. Anchoring strategy to the intended U.S. pathway — whether IDE, 510(k), De Novo, PMA, or HDE — from day one prevents that rework.

    Underestimating the protocol development cycle. A protocol that has not been stress-tested against the target jurisdiction's ethics committee requirements will generate amendment cycles. Each cycle in a slower jurisdiction adds weeks or months to the clock.

    Fragmented vendor accountability. Sponsors using separate vendors for regulatory consulting, site selection, CRO operations, and data management often find that no single party owns the end-to-end timeline. Gaps between handoffs accumulate. A single accountable team covering all workstreams from protocol through submission-ready package eliminates those gaps.

    Optimistic enrollment projections. Enrollment models built on theoretical site capacity rather than observed recruitment rates at specific sites consistently underperform. Requiring site-level enrollment data before finalizing your timeline is not pessimism — it is planning.

    How the FIH-12 Program Structures the Timeline

    bioaccess® structures its FIH-12 program around a 12-month timeline from protocol to submission-ready clinical evidence package. The program covers nine workstreams: FDA Pre-Sub and IDE/IND pathway alignment, protocol development, ethics and regulatory submissions, site activation, patient enrollment, clinical monitoring, data management, safety reporting, and CSR preparation.

    The 12-month target applies to the FIH-12 program structure; individual timelines depend on device class and regulatory pathway. But the structural design — a single accountable team, pre-qualified sites, and primary execution in jurisdictions where approvals are observed in 30 to 90 days — is what makes that target achievable for most early-feasibility device studies.

    The FIH Launch Planner on the bioaccess® site takes six questions and outputs a preliminary country route, timeline range, and evidence package estimate. For sponsors still in the planning phase, it is a useful first step toward a grounded sense of what their specific program might look like before issuing an RFP.

    FAQs

    What is the typical timeline for a first-in-human trial from protocol approval to last patient out?

    For a small FIH cohort of 10 to 30 patients, the enrollment and follow-up phases alone range from approximately four to twelve months. Add regulatory approvals and site activation, and the total range is seven to eighteen months in an optimized Latin American execution versus eighteen to forty months in a typical U.S. program.

    Does running a first-in-human trial in Latin America affect FDA acceptance of the data?

    No, provided the data is collected under the right framework. Latin American FIH data structured per FDA 21 CFR 812.28 and collected under ICH-GCP and ISO 14155 standards is accepted for U.S. IDE and IND submissions. Geographic origin does not reduce regulatory acceptability when the collection standards are met.

    What is "last patient out" and why does it matter for trial planning?

    Last patient out (LPO) is the date the final enrolled patient completes their last protocol-required visit. It marks the formal end of data collection and triggers data lock, statistical analysis, and CSR preparation. Because your submission timeline and funding milestones are anchored to it, LPO is one of the most important dates to plan around from the start.

    What causes the most timeline slippage in first-in-human trials?

    The most common causes are delayed regulatory strategy alignment, optimistic enrollment projections, protocol amendment cycles, and fragmented vendor accountability across workstreams. Each adds weeks or months to the timeline — and they tend to compound each other.

    How long does regulatory and ethics approval take for a first-in-human trial?

    In the United States or EU, regulatory and ethics approval typically takes six to twelve months. In Panama, El Salvador, Chile, and the Dominican Republic, approvals are observed in 30 to 90 days. This difference is structural to those jurisdictions, not a case-by-case exception.

    What is the difference between first patient in and last patient out?

    First patient in (FPI) is the date the first enrolled patient receives the investigational treatment or device. Last patient out (LPO) is the date the final enrolled patient completes all protocol-required follow-up visits. The interval between FPI and LPO reflects the combined enrollment duration and follow-up window across the full cohort.

    How many patients are typically enrolled in a first-in-human trial?

    FIH cohort sizes vary by device class and study design, but early feasibility studies for medical devices commonly enroll between 10 and 30 patients. The cohort is sized to generate initial safety and feasibility data, not to power a definitive efficacy conclusion. The FDA's guidance on early feasibility studies provides the framework for determining appropriate cohort size for a given device category.

    Plan the Timeline Before the Board Asks

    The most expensive FIH mistake is not a failed enrollment or a regulatory rejection. It is a timeline that was never grounded in how approvals, site activation, and enrollment actually work in the chosen jurisdiction.

    If you are 12 to 24 months from needing first human data, the time to map your timeline is now — not when the IDE is approved and the board is asking for a start date. A realistic phase-by-phase plan, built around a jurisdiction where approvals are observed in 30 to 90 days and sites are already qualified, is the difference between delivering FIH data before your next round closes and explaining to investors why it slipped.

    Learn more about how bioaccess® structures the FIH timeline at bioaccessla.com.

  • First-in-Human Clinical Trial: What Happens in Each of the Nine Workstreams

    First-in-Human Clinical Trial: What Happens in Each of the Nine Workstreams

    A first-in-human clinical trial is one of the most consequential milestones in any medical device or biopharma program. It's the moment your technology moves from bench to body — and every decision made in the months before that first procedure shapes whether your data will hold up to FDA scrutiny, satisfy your board, and carry you to the next funding round.

    Most sponsors underestimate how many distinct workstreams run in parallel before, during, and after a FIH study. It's not simply "get IRB approval, enroll patients, collect data." There are nine discrete areas of execution, each with its own regulatory requirements, dependencies, and failure modes. Understanding what happens in each one helps you ask sharper questions of any CRO you evaluate — and helps you spot the gaps before they become delays.

    This article walks through all nine workstreams in practical terms, with the regulatory grounding a sponsor-facing audience actually needs.

    Why the Nine-Workstream Model Matters

    FIH programs fail or stall for predictable reasons: a protocol that doesn't survive ethics review, a site that was never properly qualified, enrollment projections that were never stress-tested against the actual patient population, or a data package that arrives at FDA needing remediation before anyone can review it.

    Each of those failure modes maps to a specific workstream. When accountability for any one of them is unclear — or split across multiple vendors — the risk compounds. A single team holding ownership across all nine workstreams is a structural advantage, not a marketing claim.

    The nine workstreams described below reflect the architecture of the bioaccess® FIH-12 program, which carries a 12-month timeline guarantee from protocol to submission-ready evidence package.

    Workstream 1: FDA Pre-Submission and Regulatory Pathway Alignment

    Before a single patient is enrolled, you need clarity on which regulatory pathway applies to your device or molecule — and whether your FIH data strategy will satisfy FDA's evidentiary expectations.

    For medical devices, that typically means a Pre-Submission (Pre-Sub) meeting with FDA to align on IDE requirements, study design, and the evidence package FDA will need before granting clearance or approval. For drug or combination products, IND pathway alignment serves the same function.

    If your FIH study is conducted outside the US, this workstream also covers FDA 21 CFR 812.28 compliance — the framework governing how foreign clinical data from IDE studies is structured for US submission. Data collected under ISO 14155 protocol architecture and ICH-GCP standards satisfies this requirement when properly documented.

    Getting this workstream right at the start prevents costly protocol amendments and data gaps down the line.

    Workstream 2: Jurisdiction Selection and Regulatory Strategy

    Where you run your FIH study determines how fast you can start it, what it costs per patient, and how cleanly the data bridges back to FDA.

    Ethics and regulatory approvals in Panama (MINSA/CNBI), El Salvador (SRS/CNEIS), Chile (ISP/MINSAL), and the Dominican Republic are observed in 30 to 90 days. That compares to 6 to 12 months in the US. For a startup operating on a 12-to-18-month runway between funding rounds, that difference is material.

    Jurisdiction selection also affects site access, patient population characteristics, and per-patient cost structure. This workstream produces a documented country route recommendation — with a timeline range and evidence package estimate — tied to your specific device or molecule.

    Workstream 3: Protocol Development

    The protocol is the operating document for everything that follows. A weak protocol creates downstream problems at every stage: ethics rejection, site confusion, data inconsistencies, and FDA questions during review.

    A strong FIH protocol defines the study design (typically a prospective, single-arm feasibility study for devices), primary and secondary endpoints, inclusion and exclusion criteria, safety monitoring rules, stopping criteria, and the statistical framework for the evidence package.

    For medical devices, ISO 14155 governs protocol architecture. For drug or combination products, ICH E6(R2) GCP applies. In practice, both frameworks demand the same discipline: endpoints that are measurable, criteria that are defensible, and a safety monitoring plan that satisfies both the ethics committee and FDA.

    Protocol development in this workstream also includes the informed consent document, adapted to the language and regulatory requirements of the operating jurisdiction.

    Workstream 4: Ethics and Regulatory Submissions

    Once the protocol is finalized, it goes to the relevant ethics committee and regulatory authority in the operating jurisdiction. This is where jurisdiction selection pays off most directly.

    In Panama, the Comité Nacional de Bioética de la Investigación (CNBI) and MINSA review submissions concurrently. In Chile, ISP and MINSAL handle device and drug trials respectively. In El Salvador, the SRS and CNEIS process submissions in parallel. Each jurisdiction has a defined review window, and across the four primary operating jurisdictions, that window falls within 30 to 90 days.

    This workstream covers preparation of the full submission dossier — protocol, investigator brochure or device description, informed consent forms, investigator CVs, and site documentation — formatted to each authority's requirements.

    Workstream 5: Site Activation

    Site activation is one of the most underestimated sources of delay in FIH programs. A site that looks qualified on paper may have no experience with your device category, an investigator overcommitted to other trials, or a pharmacy that can't handle your product's storage requirements.

    This workstream covers site feasibility assessment, investigator qualification review, site initiation visits, and execution of clinical trial agreements and financial disclosure forms. For radiopharmaceutical programs involving Lu-177, Ac-225, or Ga-68, site activation also includes verification of radiopharmacy infrastructure and isotope handling protocols.

    A pre-qualified site network eliminates most of the feasibility risk. With 50-plus pre-qualified sites across 19 Latin American and Caribbean markets, site selection becomes a matching exercise — not a cold-start recruitment effort.

    Workstream 6: Patient Enrollment and Retention

    Enrollment projections are where optimism most reliably collides with reality. Sites routinely overestimate their eligible patient population, and sponsors routinely underestimate the time from site activation to first patient in.

    This workstream covers enrollment planning — site-level projections, screen failure rate assumptions, and enrollment rate modeling — along with patient identification and screening, informed consent execution, and retention strategies for the duration of follow-up.

    In Latin American markets, patient populations for many device indications are larger, less fragmented across competing trials, and more accessible through established referral networks. That structural advantage translates directly into faster enrollment timelines.

    Workstream 7: Clinical Operations and Safety Monitoring

    Once patients are enrolled, clinical operations covers everything happening at the site level: procedure execution, adverse event capture, protocol deviation management, and ongoing safety monitoring.

    Safety monitoring is particularly intensive in FIH studies. With no prior human safety data to anchor your stopping rules, the stakes of every adverse event are higher. This workstream includes the Data Safety Monitoring Board (DSMB) or equivalent safety review mechanism, real-time adverse event reporting to the ethics committee and regulatory authority, and site monitoring visits — on-site or remote — to verify protocol compliance.

    ICH-GCP and ACRP-certified clinical operations staff are the standard here. Monitoring visit reports, deviation logs, and safety narratives generated in this workstream feed directly into the final evidence package.

    Workstream 8: Data Management and Biostatistics

    Data management converts raw clinical observations into a structured, auditable dataset. This workstream covers EDC system setup and validation, data entry and query resolution, database lock, and statistical analysis.

    For FDA submissions, the data package must be structured in a format that supports review without remediation — clean audit trails, resolved queries, and a statistical analysis plan that was pre-specified in the protocol, not reverse-engineered after database lock.

    Biostatistics in FIH studies is typically descriptive rather than inferential. The goal is to characterize safety and initial performance signals, not to power a hypothesis test. But the statistical analysis plan still needs to be prospectively defined and executed consistently.

    Workstream 9: Regulatory Submission Package Preparation

    The final workstream converts the completed study into a submission-ready evidence package for FDA. For device programs, that's the clinical section of a 510(k) or PMA submission, or the clinical data module of an IDE application for the next study phase. For drug programs, it's the clinical study report (CSR) and the relevant IND amendment.

    This workstream covers the clinical study report, summary of safety and effectiveness data (SSED), tabulations, listings, and figures (TLFs), and the narrative sections that contextualize the data for FDA reviewers.

    Data collected under ISO 14155 and structured per FDA 21 CFR 812.28 is accepted for US IDE and IND submissions. The submission-ready package produced here is the deliverable that closes the FIH milestone and opens the door to the next funding conversation.

    How the Nine Workstreams Fit Together

    The workstreams don't run strictly in sequence. Workstreams 1 and 2 — regulatory pathway alignment and jurisdiction selection — must complete before Workstream 3 (protocol development) can finalize. Workstreams 4 and 5 (ethics submissions and site activation) run in parallel. Workstreams 6, 7, and 8 (enrollment, clinical operations, and data management) overlap throughout the active study period. Workstream 9 begins before database lock, as report templates and statistical shells are built during the study.

    Managing those dependencies without a single accountable team is where most programs lose time. When the protocol team, the regulatory team, the site team, and the data team operate in silos, handoffs become bottlenecks.

    The bioaccess® FIH-12 program is structured around single-team ownership of all nine workstreams, with a 12-month timeline guarantee from protocol to submission-ready evidence package. If you're at the stage of mapping out your FIH program, the FIH Launch Planner on the bioaccess® website generates a preliminary country route, timeline range, and evidence package estimate based on six questions about your program.

    FAQs

    What is a first-in-human clinical trial?
    A first-in-human clinical trial is the initial study in which a new medical device, drug, or combination product is tested in human subjects for the first time. For medical devices, it typically takes the form of an early feasibility study (EFS) designed to assess safety and initial performance signals before a larger pivotal trial.

    How long does a first-in-human clinical trial take?
    Timeline depends heavily on jurisdiction and program structure. In the US or EU, ethics and regulatory approvals alone can take 6 to 12 months. In Panama, El Salvador, Chile, and the Dominican Republic, those approvals are observed in 30 to 90 days. A structured FIH program covering all nine workstreams — from protocol to submission-ready evidence package — can be completed in 12 months in those jurisdictions.

    Does FDA accept clinical data collected outside the United States?
    Yes. Under FDA 21 CFR 812.28, foreign clinical data from IDE studies conducted outside the US is accepted for US submissions when the study is conducted under ISO 14155 protocol architecture and ICH-GCP standards, and when the data is properly documented and structured for FDA review.

    What is the difference between an early feasibility study and a pivotal trial?
    An early feasibility study or FIH study is designed to generate initial safety and performance data in a small patient cohort, typically 10 to 30 subjects. A pivotal trial is a larger, statistically powered study designed to support a marketing authorization — 510(k), PMA, or NDA/BLA. FIH data often feeds directly into the design of the pivotal trial and may be included in the marketing submission.

    What does "submission-ready evidence package" mean?
    A submission-ready evidence package is a complete, auditable clinical data package formatted for FDA review. It includes the clinical study report, statistical analysis outputs, safety narratives, and supporting documentation structured to satisfy the evidentiary requirements of a 510(k), PMA, IDE, or IND submission. It's the deliverable that closes the FIH milestone.

    Why does single-team accountability across all nine workstreams matter?
    When different vendors own different workstreams, handoffs create delays and accountability gaps. A protocol amendment requested by the ethics committee may not reach the data management team in time to update the EDC. A site activation delay may not be reflected in enrollment projections until the sponsor is already behind. Single-team ownership eliminates those gaps by keeping all nine workstreams under one accountable point of contact.

    What is the per-patient cost for a first-in-human study in Latin America?
    Per-patient costs in Panama range from $12,000 to $22,000 — materially below US CRO pricing for comparable FIH programs. Total program cost depends on the number of subjects, the device or molecule category, the number of sites, and the scope of the evidence package required.

    Plan Your FIH Program Around the Full Nine Workstreams

    Most FIH delays aren't caused by science. They're caused by gaps in planning, unclear ownership, and jurisdictions that weren't selected with regulatory speed in mind.

    Understanding what happens in each workstream gives you a framework for evaluating any CRO you consider — and for stress-testing your own timeline assumptions before you commit to a board milestone or investor deadline.

    If you're mapping out your first-in-human program, bioaccess® covers all nine workstreams under a single team, with a 12-month timeline guarantee and operations across 19 Latin American and Caribbean markets.

    WordPress Category: Navigating Regulatory Landscapes in Latin America

  • Importer of record vs. registration holder in Latin America: the medical device guide

    Short answer: the importer of record (IOR) answers for a shipment, while the registration holder answers for the license. The IOR is the local legal entity responsible for a specific consignment at customs. The registration holder is the entity named on the sanitary registration, the permit that lets a medical device be sold in the country at all. In some Latin American markets one registration can carry several importers. In others, the holder and the importer have to be the same entity. Which model applies decides who controls your market access when you change distributors.

    This page brings together our IOR-vs-holder guide and our country-by-country importer of record reference. Every country rule below names the regulation it comes from.

    The two roles, side by side

    Importer of record (IOR) Registration holder
    What it is accountable for A specific shipment: the customs declaration, tariff classification, duties and VAT/IVA, and any import authorization the health authority requires The sanitary registration itself: who may market the device, renewals, label and configuration changes, and technovigilance
    Local names Importador, importador autorizado Titular del registro (Colombia, Mexico, Peru, Ecuador), detentor do registro (Brazil), Argentina Authorized Representative
    Liability when something goes wrong At the port: a held or rejected consignment In the market: a suspended, cancelled or contested registration
    What changing it involves In multi-importer markets, an amendment to the registration’s importer list A formal transfer that the current holder has to sign

    A customs broker is neither of these. The broker files paperwork as the importer’s agent but does not carry the importer’s legal accountability.

    The two gates every device passes through

    Gate one is customs. The IOR handles the entry filing, duties and any import permit, and it keeps the records that later audits rely on. If the importer named on the customs filing is not an entity authorized under the sanitary registration, the shipment can be held.

    Gate two is the health authority. The registration holder owns the registration and carries the post-market duties: vigilance reporting, renewals, labeling amendments and any change that needs a registration update. In multi-importer markets it also decides which importers are listed. Solving gate one while ignoring gate two leaves a problem that surfaces the day you want to change distributors.

    Multi-importer markets vs. single-IoR markets

    In a multi-importer market, one registration can name several importers, and the holder adds or removes them by amending the registration, without re-registering the device. In a single-IoR market, the registration is tied to one local entity that is both holder and importer. Distributors can still sell downstream, but only one party is accountable to the regulator.

    The practical consequence: if a distributor holds your registration, especially in a single-IoR market, that distributor controls your market access. We call this the registration-hostage problem. A neutral holder that does not sell your product removes that leverage.

    How the main regulators structure the roles

    Brazil (ANVISA): one detentor, importers authorized under it

    RDC 751/2022 regulates device regularization, and each registration or notification has a single detentor, which must be a company licensed in Brazil. The detentor can authorize other licensed companies to import under its registration. Changing the detentor itself is a transfer of titularidade under RDC 903/2024, which replaced RDC 102/2016. The transfer is allowed only after a corporate or commercial operation, the petitions are due within 180 days, and products regularized by notificação cannot be transferred (Articles 26 and 28).

    Mexico (COFEPRIS): the titular can list several distributors and importers

    The registro sanitario is granted under the Reglamento de Insumos para la Salud, and the titular (often called the Mexico Registration Holder) carries product compliance in Mexico. One registration can support several distributors and importers. Moving the registration to a new titular is a cesión de derechos. It is filed as a modification under homoclave COFEPRIS-2022-022-003, it needs a notarized contract, and it must be notified within 30 business days.

    Colombia (INVIMA): “un titular con varios importadores”

    INVIMA’s own guidance refers to a registration with “un titular con varios importadores” (one holder with several importers) and makes the titular responsible for the UDI-DI and semantic-standard report under Resolución 1405 de 2022. Under Decreto 4725 de 2005, the manufacturer authorizes a Colombian-domiciled entity to import and, where applicable, to be the titular. Each importer must have its own corporate purpose covering device import, and INVIMA requires a storage and conditioning certificate (CCAA) where it applies. A change of titular is an automatic modification under Article 30 of Decreto 4725, as substituted by Decreto 582 de 2017, and it needs a cesión signed by both parties.

    Peru (DIGEMID): the titular must be a licensed droguería or laboratorio

    Under the device regulation, DS 016-2011-SA as updated by DS 020-2024-SA, only a pharmaceutical establishment authorized as a droguería or a device laboratorio can apply for a device registro sanitario. The registration lets its titular import, store, distribute and sell the device. A registration can be transferred only by its titular and only to another qualified establishment (Article 8). An independent licensed droguería can therefore hold the registration in place of a distributor.

    Argentina (ANMAT): holder and importer are the same entity

    Device registration follows Disposición ANMAT 64/2025, which incorporated MERCOSUR Resolución GMC 25/21 and repealed Disposición 2318/2002 and its consolidated text, Disposición 1285/2004. It took effect for new registrations on January 21, 2025. The local registrant is both the registration holder and the importer, so there is one Argentina Authorized Representative per registration. Argentina is a strictly single-IoR market.

    Ecuador (ARCSA): one titular per certificate

    ARCSA’s device rules, now consolidated in Resolución ARCSA-DE-2026-003-DASP, issue the certificado de registro sanitario in the name of a single titular. That titular is legally and technically responsible for the product’s quality and safety in Ecuador. The applicant can be the manufacturer, its legal representative or an authorized distributor in Ecuador. Treat Ecuador as single-holder.

    For the other markets, including Paraguay, the Dominican Republic, Panama, Costa Rica, Central America and the Caribbean, see the importer of record country reference and the medical device registration guide.

    Four questions to answer before you appoint anyone

    1. Is the country multi-importer or single-IoR for your device? The answer sets how much room you have to change partners later.
    2. Who will hold the registration, and what are the transfer terms? A registration held by a distributor with no written path to transfer it is a liability.
    3. Can one partner cover both roles where the country requires it? If not, you need two providers working closely together.
    4. What is the written procedure to add or remove an importer, or to transfer the registration? Agree on it before signing. Every transfer route in the region needs the current holder’s signature.

    Common mistakes

    • Treating IOR and holder as the same thing because one vendor offers both. They are governed separately and fail separately.
    • Appointing a distributor as holder without checking the country model. In Argentina or Ecuador that decision is hard to reverse quickly.
    • Import documents that name an entity not authorized under the registration. Customs and health authorities cross-check them.
    • Leaving the transfer clause out of the distribution agreement. When the relationship ends, a holder who won’t sign leaves you with a new registration and a supply gap.

    If a holder change is already on the table, our guide to transferring a medical device registration to a new holder in Brazil, Mexico, Colombia and Peru walks through each agency’s procedure. The country holder guides for Brazil, Mexico and Colombia cover the first filing.

    Frequently asked questions

    What is the difference between an importer of record and a registration holder?

    The importer of record is legally responsible for a specific shipment clearing customs. The registration holder owns the sanitary registration that allows the device to be marketed, and it carries the post-market obligations. In single-IoR markets such as Argentina, one entity does both.

    Is the customs broker the importer of record?

    No. The broker files on the importer’s behalf as an agent. The importer of record keeps the legal accountability.

    Can one registration have several importers?

    In Colombia, Mexico and Brazil, yes: the holder authorizes or lists additional importers without re-registering the device. In Argentina and Ecuador, the registration is tied to a single local holder.

    Can a distributor hold my registration?

    Usually, yes. If the relationship ends, though, moving the registration needs that distributor’s signature in every major market. A neutral holder avoids that dependency.

    What happens when I change distributors?

    In a multi-importer market, the holder amends the registration to add the new importer and remove the old one. If the distributor was also the holder, you need a formal transfer, such as a cesión de derechos in Mexico or Colombia or a transfer of titularidade in Brazil, signed by the outgoing holder.

    Where bioaccess® fits

    bioaccess® acts as a neutral registration holder across our Latin American coverage. Because we keep regulatory control separate from commercial distribution, you can appoint, change or add distributors without a registration crisis. To map which model applies to your device in each target market, start at bioaccess® market access or contact our team.

    Sources

    • ANVISA, RDC 751/2022 (device regularization) and RDC 903/2024 (transfer of titularidade), Articles 26 and 28
    • COFEPRIS, Reglamento de Insumos para la Salud; modification procedure COFEPRIS-2022-022-003 (cesión de derechos)
    • INVIMA, Decreto 4725 de 2005 (Article 30, as substituted by Decreto 582 de 2017); INVIMA guidance on the estándar semántico under Resolución 1405 de 2022; INVIMA medical device registration requirements
    • DIGEMID, DS 016-2011-SA (Articles 8 and 19, as updated by DS 020-2024-SA)
    • ANMAT, Disposición 64/2025 (MERCOSUR Resolución GMC 25/21), published in the Boletín Oficial on January 13, 2025
    • ARCSA, Resolución ARCSA-DE-2026-003-DASP (device registration technical rule)

    Julio G. Martinez-Clark, CEO, bioaccess®

  • Early Feasibility Study in Latin America: Regulatory Requirements and Site Criteria

    Early Feasibility Study in Latin America: Regulatory Requirements and Site Criteria

    Running an early feasibility study (EFS) outside the United States is not a workaround. For many MedTech and biopharma sponsors, it is the most direct path to a first-in-human dataset the FDA will actually accept. Latin America has become a serious destination for EFS execution because its regulatory timelines, site infrastructure, and per-patient economics align with what early-stage sponsors genuinely need.

    This article covers what an EFS requires across Latin American jurisdictions, which regulatory bodies are involved, what site qualification looks like in practice, and how the data you collect gets structured for your U.S. regulatory pathway.

    What an Early Feasibility Study Is and Why It Matters

    An early feasibility study is a small, limited first-in-human (FIH) clinical investigation designed to evaluate initial device or therapy performance, safety signals, and proof-of-concept in a human population. It typically precedes a pivotal trial and generates the foundational clinical evidence that informs protocol refinement, device iteration, and regulatory submissions.

    In the U.S., the FDA's EFS pathway under the IDE framework is well-defined but slow. Ethics and IDE approvals routinely take 6 to 12 months before a single patient is enrolled. For a startup with 18 months of runway and a Series A milestone tied to first human data, that timeline simply does not work.

    Latin American jurisdictions offer a structurally different environment. Ethics and regulatory approvals in Panama (MINSA/CNBI), El Salvador (SRS/CNEIS), Chile (ISP/MINSAL), and the Dominican Republic are observed in 30 to 90 days. That is not a promotional claim — it reflects documented operating experience running trials through those authorities. The health authorities retain full discretion over their review timelines; the 30-to-90-day range describes what sponsors actually encounter, not a contractual commitment from any regulatory body.

    Regulatory Requirements by Jurisdiction

    Panama (MINSA/CNBI)

    Panama's Ministry of Health (MINSA) and the National Bioethics Committee (CNBI) jointly govern clinical research approvals. Panama is one of the most commonly selected EFS jurisdictions in Latin America, valued for its approval speed, English-language familiarity in the clinical community, and established infrastructure for international trials.

    For a device EFS, the sponsor typically submits a clinical investigation protocol, investigator brochure or device description, informed consent forms, investigator CVs, site credentials, and evidence of GCP training. CNBI review focuses on ethical adequacy of the study design, subject protection, and risk-benefit framing. MINSA review addresses the regulatory classification of the device and the adequacy of the investigation plan.

    Per-patient costs in Panama range from $12,000 to $22,000 — materially lower than comparable FIH trial costs in the U.S.

    El Salvador (SRS/CNEIS)

    El Salvador's Regulatory Health Authority (SRS) and the National Ethics Committee for Health Research (CNEIS) handle clinical investigation approvals. El Salvador is a viable option for sponsors seeking a second site or a parallel enrollment pathway alongside Panama. The review structure is similar: protocol submission, ethics committee review, and authority-level regulatory clearance before site initiation.

    Chile (ISP/MINSAL)

    Chile's Public Health Institute (ISP) and Ministry of Health (MINSAL) govern clinical research. Chile has a more developed clinical research infrastructure than many other markets in the region, with experienced principal investigators and academic medical centers that are well-acquainted with ISO 14155 protocol architecture. For sponsors pursuing CE mark pathways in parallel with FDA submissions, Chile's regulatory environment is particularly relevant.

    Other Jurisdictions

    The operating footprint for EFS execution spans 19 Latin American and Caribbean markets, including Colombia, the Dominican Republic, Peru, Argentina, Brazil, and Mexico. Each jurisdiction has its own ethics committee and regulatory authority structure. Country selection for a specific EFS depends on device classification, therapeutic area, site capability, patient population availability, and the sponsor's intended regulatory pathway.

    How Latin American EFS Data Gets Accepted by the FDA

    This is the question sponsors ask most often, and it has a clear regulatory answer. FDA 21 CFR 812.28 governs the acceptance of foreign clinical data in IDE submissions. Data collected outside the U.S. is acceptable when the investigation was conducted in accordance with Good Clinical Practice (GCP), the submission includes a detailed description of the foreign regulatory framework, and the sponsor demonstrates that the data is relevant to the U.S. population and intended use.

    In practice, this means the protocol must be structured to ICH-GCP and ISO 14155 standards from the outset, the ethics and regulatory approval process must be fully documented, and the final clinical study report must be organized in a format that maps directly to the FDA's evidentiary expectations.

    Sponsors who try to retrofit a Latin American dataset into an FDA submission after the fact typically run into problems. The data package needs to be built for FDA use before the first patient is enrolled — not after the study closes.

    This is why pre-submission alignment with the FDA matters. A Pre-Sub meeting that confirms your EFS protocol, country selection, and evidence package structure are acceptable to the FDA before you start protects the value of everything you collect.

    Site Qualification Criteria for an Early Feasibility Study

    Not every clinical site in Latin America is appropriate for an EFS. The criteria that matter most are:

    Principal Investigator experience. The PI must have documented experience with the device type or therapeutic area, GCP certification, and familiarity with ISO 14155 for device studies. For novel device categories, the PI's ability to recognize and manage unanticipated adverse events is a primary selection criterion.

    Facility capability. The site must have the equipment, staffing, and emergency response infrastructure to support the specific procedure or intervention being studied. A cardiovascular device EFS has different facility requirements than one involving a diagnostic tool.

    IRB/ethics committee relationship. Sites with established relationships with the relevant national ethics committee — CNBI, CNEIS, or equivalent — move through the approval process more predictably. A site submitting to CNBI for the first time will face a longer runway than one with an established submission history.

    Regulatory compliance history. Sites should have a clean inspection record and documented SOPs for source data verification, adverse event reporting, and protocol deviation management. For FDA-bridgeable data, the site's compliance posture directly affects the data's credibility in a U.S. submission.

    Patient population access. EFS enrollment is typically small — often 5 to 30 subjects — but the site must have realistic access to the target population. Enrollment delays in an EFS are expensive relative to the study size. Sites with pre-screened patient registries or active referral networks in the relevant indication are preferable.

    A network of 50-plus pre-qualified sites across a 19-country footprint means site selection can be matched to therapeutic area, enrollment feasibility, and country-level regulatory considerations rather than defaulting to whatever site is geographically convenient.

    Protocol Architecture for a Latin American EFS

    The protocol for a Latin American EFS must satisfy two audiences simultaneously: the local ethics committee and regulatory authority, and the FDA reviewer who will eventually evaluate the data.

    Key protocol elements that affect both:

    • Primary and secondary endpoints must be defined with enough specificity to generate interpretable data, but the EFS is not a pivotal study. The FDA expects EFS data to be exploratory and hypothesis-generating, not statistically powered for regulatory approval.
    • Subject selection criteria must be defensible to the local ethics committee and relevant to the U.S. intended use population. If the enrolled population differs meaningfully from the U.S. target population, the sponsor needs to address that in the FDA submission.
    • Stopping rules and safety monitoring must be explicit. Ethics committees in Panama, El Salvador, and Chile expect clear criteria for study suspension and a defined safety monitoring process.
    • Data collection instruments must be structured for electronic data capture (EDC) systems that produce audit-ready, FDA-compatible data exports. Paper-based data collection in a 2026 EFS creates unnecessary friction in the FDA submission process.
    • Informed consent must be translated, culturally adapted, and approved by the local ethics committee. Submitting a U.S.-formatted consent form without adaptation is one of the most common sources of ethics committee delays.

    Timeline Structure for a Latin American EFS

    A realistic timeline from protocol finalization to last patient last visit looks like this:

    • Protocol development and Pre-Sub alignment: 4 to 8 weeks
    • Ethics and regulatory submission preparation: 2 to 4 weeks
    • Ethics and regulatory approval (observed): 30 to 90 days
    • Site initiation and investigator training: 2 to 4 weeks
    • Patient enrollment: Varies by indication and enrollment rate; 8 to 16 weeks is a reasonable planning assumption for a 10-to-20-subject EFS
    • Follow-up period: Defined by protocol; typically 30 days to 12 months depending on the device and endpoints
    • Data lock, analysis, and clinical study report: 8 to 12 weeks post-last visit

    When the regulatory approval phase runs 30 to 90 days rather than 6 to 12 months, the total elapsed time from protocol finalization to a submission-ready evidence package can fit within 12 months. That compression is what makes Latin America structurally different from U.S. or EU EFS execution for time-constrained sponsors.

    What the Evidence Package Needs to Contain

    When the EFS closes, the sponsor needs more than a clinical study report. An FDA submission-ready evidence package typically includes:

    • Final clinical study report (CSR) structured per ICH E3 or equivalent
    • Protocol and all approved amendments
    • Ethics committee and regulatory authority approvals for each site and country
    • Informed consent documentation
    • Investigator CVs and GCP training records
    • Site qualification documentation
    • Source data verification (SDV) records
    • Adverse event and serious adverse event (SAE) narratives
    • Device accountability records
    • Statistical analysis plan and output datasets
    • Organized data room with document indexing aligned to the sponsor's FDA submission format

    The data room structure matters more than sponsors often expect. An FDA reviewer evaluating an IDE submission that includes foreign clinical data needs to locate every supporting document quickly. Disorganized data rooms slow FDA review and generate unnecessary information requests.

    Working with a CRO That Knows Both Sides

    Running an EFS in Latin America requires a team that understands both the local regulatory environment and the FDA's expectations for foreign clinical data. Those are not the same skill set, and the gap between them is where sponsors lose time and data value.

    bioaccess® operates across 19 Latin American and Caribbean markets with regulatory authority integrations active in Panama, El Salvador, and Chile, and a network of 50-plus pre-qualified sites. The FIH-12 program covers all nine workstreams from protocol development through final evidence package delivery, with the entire process structured for FDA acceptance under 21 CFR 812.28. Intake is limited to eight new programs per quarter — worth knowing if your timeline is anchored to an investor milestone or board deadline.

    FAQs

    What is an early feasibility study, and how does it differ from a pivotal trial?
    An early feasibility study is a small first-in-human investigation designed to generate initial safety and performance data for a device or therapy. It is exploratory and typically enrolls 5 to 30 subjects. A pivotal trial is statistically powered to support a regulatory approval decision and enrolls a much larger population. EFS data informs protocol design and device refinement before a pivotal study begins.

    Can data from a Latin American early feasibility study be used in an FDA IDE or 510(k) submission?
    Yes. Under FDA 21 CFR 812.28, foreign clinical data is acceptable in IDE submissions when the investigation was conducted in accordance with GCP and the data is relevant to the U.S. population and intended use. The protocol must be structured for FDA acceptance from the start, and the evidence package must meet FDA evidentiary standards.

    How long does regulatory approval take for an EFS in Panama or Chile?
    Ethics and regulatory approvals in Panama (MINSA/CNBI), Chile (ISP/MINSAL), and El Salvador (SRS/CNEIS) are observed in 30 to 90 days. These are observed timelines based on operating experience in those jurisdictions, not contractual guarantees from the health authorities.

    What site criteria matter most when selecting a Latin American site for an EFS?
    The most important factors are principal investigator experience with the device type or therapeutic area, facility capability for the specific procedure, the site's established relationship with the national ethics committee, regulatory compliance history, and realistic access to the target patient population.

    Does the EFS protocol need to be different for a Latin American submission versus a U.S. submission?
    The core scientific and clinical content should be consistent. The protocol will need to be adapted for local ethics committee requirements, including translated informed consent forms and culturally appropriate subject communication. The protocol architecture should satisfy both ICH-GCP/ISO 14155 standards and the FDA's expectations for foreign clinical data from the outset.

    What is the typical per-patient cost for an EFS in Panama?
    Per-patient costs in Panama range from $12,000 to $22,000 — materially lower than comparable per-patient costs in U.S. clinical trial settings.

    How do I know which Latin American country is right for my EFS?
    Country selection depends on your device classification, therapeutic area, target patient population, and intended U.S. regulatory pathway. Ethics committee review speed, site capability in your indication, and country-level regulatory classification of your device all factor into the decision. The FIH Launch Planner at bioaccessla.com can generate a preliminary country route and timeline estimate based on your specific program inputs.

    Start with the Right Structure

    An early feasibility study in Latin America is not a shortcut. It is a structured clinical investigation that has to satisfy both local regulatory authorities and the FDA's standards for foreign clinical data. The speed advantage is real — but only when the protocol, site selection, ethics submissions, and evidence package are built correctly from the beginning.

    If you are 12 to 18 months from needing first human data and your timeline cannot absorb a 12-month U.S. regulatory approval process before enrollment starts, Latin America deserves serious evaluation. The regulatory infrastructure is there. The site network is there. The question is whether your evidence package will be built to cross the FDA finish line.

    Learn more at bioaccessla.com.

  • Clinical Development Plan Template: What to Include Before Your First FDA Meeting

    Clinical Development Plan Template: What to Include Before Your First FDA Meeting

    A clinical development plan is the document that separates sponsors who walk into a Pre-Sub meeting ready to have a productive conversation from those who walk in with questions FDA already expects them to have answered. Whether your first FDA meeting is a Pre-Sub (Q-Sub), a Pre-IDE, or an early Type B interaction, the plan you bring shapes how the agency reads your program's maturity.

    This article gives you a practical template: what sections to include, what each one needs to accomplish, and where sponsors most often leave gaps that slow things down.

    What a Clinical Development Plan Actually Does

    A clinical development plan (CDP) is not a protocol. It is the strategic document that explains your overall clinical evidence strategy across the full arc of your program — from first-in-human through pivotal, and ultimately to your target regulatory submission.

    FDA reviewers use it to assess whether you understand the evidentiary requirements for your intended pathway, whether your proposed study designs will actually generate data that supports that pathway, and whether your risk management thinking is credible.

    For a medical device startup, the CDP is often the first document that demonstrates regulatory competence to both FDA and your investors. Getting it right before that first meeting matters.

    Core Sections to Include

    1. Device or Product Description

    Start with a clear, concise description of what the device does, how it works, and what it is made of. Include your intended use statement and indications for use as currently drafted — these will evolve, but FDA needs to understand what you are talking about before evaluating anything else.

    If you are pursuing a 510(k), identify the predicate device here. If you are on a De Novo or PMA pathway, state that explicitly and explain why.

    2. Regulatory Pathway and Target Submission Type

    Specify your intended submission type: IDE, 510(k), De Novo, PMA, or HDE. Explain the rationale. If you have not yet determined the pathway, that is a legitimate question to bring to the Pre-Sub — but present your current working hypothesis with supporting reasoning, not a blank.

    Include a brief summary of any prior FDA feedback and how your current plan responds to it.

    3. Preclinical Evidence Summary

    Summarize the bench testing, biocompatibility data, and animal study results you have completed or have underway. FDA will want to see that you have addressed basic safety questions before moving to human subjects.

    Identify any preclinical gaps you know exist and your plan to close them. Acknowledging gaps proactively is stronger than leaving FDA to find them.

    4. Clinical Evidence Strategy

    This is the heart of the CDP. It should describe:

    • The number and type of clinical studies planned — feasibility, FIH, pivotal
    • Primary endpoints for each study and why those endpoints are clinically meaningful
    • The patient population and inclusion/exclusion criteria rationale
    • Sample size justification, even if preliminary
    • The statistical analysis approach
    • How data from each study feeds into the next and ultimately supports your target submission

    For a first-in-human study, the primary focus is safety and initial feasibility. Your CDP should explain how the FIH study design addresses the specific risks identified in your preclinical program and how the resulting data will be structured to support the next study or a direct regulatory submission.

    5. Risk-Benefit Framework

    Describe the clinical risks associated with the device and how your study design mitigates them. Reference your risk management file and any relevant ISO 14971 analysis. FDA expects to see that your clinical endpoints and stopping rules connect to your risk assessment — not that they were developed in isolation.

    For novel devices or high-risk indications, this section carries significant weight. A shallow risk-benefit analysis signals that the sponsor has not fully thought through the human subjects implications.

    6. Regulatory Strategy Timeline

    Lay out a realistic timeline from your current stage through your target submission. Include:

    • Pre-Sub or Pre-IDE meeting date, or planned date
    • IDE submission target, if applicable
    • FIH study start and completion targets
    • Pivotal study milestones, if applicable
    • Target submission date

    Be honest about uncertainty. A timeline with appropriate ranges and identified dependencies is more credible than an optimistic straight line.

    7. Geographic and Site Strategy

    Specify where you plan to conduct the clinical work and why. This section matters more than many sponsors realize. FDA reviewers are familiar with the use of foreign clinical data under 21 CFR 812.28, and they will want to understand how your site selection and data collection practices ensure the data will be acceptable for your U.S. submission.

    If any part of your clinical program will be conducted outside the United States, address the regulatory framework governing data acceptability directly. Studies conducted under ICH-GCP and ISO 14155, and structured per FDA 21 CFR 812.28, can support IDE and IND submissions. Sponsors who have run early feasibility and first-in-human studies in Latin America have successfully used that data in U.S. submissions when study design and data management standards were aligned from the start.

    bioaccess® structures its FIH-12 program specifically to produce a submission-ready clinical evidence package aligned with the sponsor's intended FDA pathway, with ethics and regulatory approvals in Panama, El Salvador, Chile, and the Dominican Republic observed in 30 to 90 days.

    8. Data Management and Monitoring Plan Summary

    You do not need a full data management plan in the CDP, but you should describe your approach to data collection, electronic data capture, monitoring frequency, and how you will ensure data integrity. FDA is increasingly attentive to data quality, particularly for studies conducted at sites outside the United States.

    Mention your quality standards: ICH-GCP compliance, audit trail requirements, and how adverse events will be captured and reported.

    9. Post-Market Clinical Follow-Up (PMCF) Plan, If Applicable

    For PMA and De Novo pathways, FDA often expects a PMCF plan even at the early development stage. If your device will require post-approval studies, include a preliminary description of that commitment. It signals that you are thinking about the full evidence lifecycle — not just the approval milestone.

    Common Gaps That Slow Down FDA Meetings

    Endpoint mismatch. The most frequent problem is proposing FIH endpoints that do not connect to the primary endpoint in the pivotal study. If your pivotal trial will measure a specific clinical outcome, your FIH study should at minimum collect data that informs your ability to measure that outcome in a larger population.

    Undefined patient population. Vague inclusion criteria at the CDP stage signal that the sponsor has not yet characterized the target population carefully enough to design a study. FDA will ask.

    No statistical rationale. Even for a small FIH study, you need to explain why the proposed sample size is sufficient to characterize safety and generate the preliminary efficacy signal you need. "N=10 because that is what we can afford" is not a rationale.

    Regulatory pathway ambiguity. If you are genuinely uncertain whether your device is a 510(k) or a De Novo, say so explicitly and frame it as a Pre-Sub agenda item. Presenting a plan that assumes a 510(k) pathway when the device is likely De Novo or PMA wastes everyone's time.

    Missing foreign data acceptability discussion. If any part of your clinical program will be conducted outside the United States, address 21 CFR 812.28 directly. Sponsors who skip this section frequently receive FDA feedback requesting clarification before the meeting can move forward productively.

    Structuring the CDP for a Pre-Sub Meeting

    FDA's Pre-Sub program is designed to give sponsors early feedback on proposed study designs and regulatory strategies. To get the most from the meeting, structure your CDP so that each section maps to a specific question you are bringing to FDA.

    Format your Pre-Sub request with numbered questions, each referencing the relevant CDP section. For example:

    • "Section 4 describes our proposed FIH study endpoints. Question 1: Does FDA agree that [specific endpoint] is an acceptable primary safety endpoint for this study?"
    • "Section 7 describes our plan to conduct the FIH study in Panama under 21 CFR 812.28. Question 2: Does FDA have concerns about the acceptability of data collected under this framework for the subsequent IDE submission?"

    This structure makes the meeting productive. Reviewers can prepare specific responses rather than reacting to a general document.

    Before You Write the CDP: Align Your Regulatory Strategy First

    The CDP is only as strong as the regulatory strategy behind it. Before drafting, you need clarity on three things: your intended submission type, your primary endpoint, and your patient population. If any of those are unresolved, the CDP will reflect that uncertainty — and the FDA meeting will spend time on foundational questions rather than specific feedback.

    If those questions are still open, working through a structured regulatory strategy exercise before drafting is worth the time. For sponsors considering a LatAm FIH execution strategy, the FIH Launch Planner at bioaccessla.com generates a preliminary country route, timeline range, and evidence package estimate based on six questions — a useful starting point for grounding the geographic and timeline sections of the CDP.

    FAQs

    What is a clinical development plan and who needs one?
    A clinical development plan is a strategic document describing the full evidence generation strategy for a medical device or drug from early development through regulatory submission. Any sponsor preparing for a first FDA meeting — whether a Pre-Sub, Pre-IDE, or Type B interaction — should have one before that meeting.

    How is a clinical development plan different from a clinical trial protocol?
    A protocol is the operational document for a single study: it specifies the design, procedures, and endpoints in detail. A CDP is the overarching strategy document that explains how multiple studies — including the protocol-governed ones — fit together to build the evidence package required for regulatory approval.

    Does FDA require a clinical development plan before a Pre-Sub meeting?
    FDA does not require a formal CDP as a named document, but the Pre-Sub meeting request must include a description of your device, your proposed study design, and specific questions for FDA. A well-structured CDP is the most efficient way to satisfy that requirement and get substantive feedback.

    Can data from a first-in-human study conducted in Latin America be used in a U.S. FDA submission?
    Yes. Foreign clinical data is acceptable to FDA under 21 CFR 812.28 when the study is conducted in accordance with ICH-GCP and the data is collected in a manner consistent with FDA requirements. Study design, endpoint selection, and data management standards must be aligned with the sponsor's intended U.S. pathway from the start.

    What endpoints should a first-in-human study include?
    For a medical device FIH study, the primary focus is safety: adverse events, device-related complications, and serious adverse device effects. Secondary endpoints typically include early feasibility signals relevant to the pivotal study's primary endpoint. The specific endpoints depend on the device type, indication, and intended regulatory pathway.

    How long should a clinical development plan be?
    There is no required length. A CDP for an early-stage device program might run 10 to 20 pages. The goal is completeness and clarity, not volume — every section should answer a specific question a regulatory reviewer or investor would ask.

    When should I update the clinical development plan?
    Update the CDP after any significant regulatory interaction, after completing a study that generates new data, and whenever your regulatory pathway or target submission type changes. It should reflect your current strategy, not the one you had at the start of the program.

    Conclusion

    A clinical development plan is not a formality. It is the document that demonstrates you have thought through the full arc of your evidence strategy before asking FDA to weigh in on any part of it. Build it section by section, connect each element to your target submission, and structure it so your Pre-Sub questions map directly to the sections where you need the agency's input. That preparation is what turns a first FDA meeting from a general orientation into a productive regulatory strategy session.

    If your clinical development plan includes a LatAm FIH execution component, visit bioaccessla.com to learn how the FIH-12 program structures that work for FDA-bridgeable outcomes.

  • Best countries for structural heart early feasibility studies

    Structural heart early feasibility is not a country-agnostic first-in-human. You need implanting volume, echo and CT that can be read the same way twice, and a site that already treats the disease you are studying. The wrong shortlist is “any fast LATAM ethics committee.” The right shortlist is a handful of hospitals that already do TAVR, TEER, or tricuspid work at a pace your sample size can survive.

    What has to be true in the country you pick

    • Operators who already perform the index procedure, not a general cath lab learning it on your device.
    • Imaging that can feed a core lab or at least a locked acquisition protocol. EFS failures in this category are often echo quality, not device quality.
    • An ethics and regulator path that can iterate. Early feasibility is supposed to change. A country that treats every protocol tweak as a new filing will erase the point of EFS.
    • Investigational import that can handle a device family, not a single serial, because you will iterate hardware.

    How I rank the usual options

    United States is still the gold standard when you already have an IDE conversation and the right sites. It is also the slowest and most expensive way to learn whether the device should even go there yet.

    Australia works when the protocol is English-native and the implanting volume exists. It is a poor default if your constraint is mitral or tricuspid enrollment speed.

    Colombia is often the first LATAM conversation for US sponsors: INVIMA plus CEI, strong cardiovascular hospitals, and a cost base that survives a 15-to-30-patient series. The calendar is the CEI and the import, not the science.

    Brazil has depth. ANVISA plus CONEP is a longer stack. Use it when you need volume and a later commercial story, not when you need the first ten patients this quarter.

    Panama and selected private systems in Mexico can be the right tactic when import and ethics are designed up front and the operator already has the volume. They are the wrong tactic when someone picked them from a map.

    The decision that actually matters

    Write the EFS protocol for the question FDA will ask next — design, procedure, or safety signal — then pick the two sites that can generate that imaging and those implants. Country is how you get those sites open. It is not the strategy.

    If a slide says “LATAM is faster” without naming the implanting physician, the imaging protocol, and the importer of record, it is not a country recommendation. It is a brochure.

  • Where to run a neurovascular first-in-human study outside the US

    Neurovascular first-in-human is a hospital procedure study with a stroke or aneurysm case mix, not a Phase 1 unit problem. When founders ask where to go outside the US, they usually mean “where can I get ten clean cases without waiting a year for an IDE.” That is a fair question. The unfair version is picking a country first and hoping the operators exist.

    What the site has to already do

    The lab must already treat the target lesion at volume. A center that does occasional coiling is not a stroke-thrombectomy FIH site. You need documented case mix, 24-hour coverage if the indication is acute, and imaging that can be reconstructed later — DSA, CT, MR — under a protocol, not “whatever the night tech ran.”

    You also need a neuro IR or dual-trained operator who will tell you when the device should not go in. Early feasibility in this category fails when the first cases are the wrong anatomy and nobody recorded why.

    OUS options that are actually used

    Australia and selected European centers if the protocol is already written for an English or EU ethics workflow and you need FDA-facing documentation more than enrollment speed.

    Colombia and other high-volume LATAM neurovascular programs when the constraint is case mix and cost, and you are willing to design INVIMA or the local authority, the CEI, and investigational import as one calendar. Stroke and aneurysm volume in large public and private systems is the asset. The risk is treating that volume as if it were an IDE site on day one without locking imaging and device accountability.

    Avoid any destination whose pitch is regulatory speed and whose case list cannot show the lesion you need. A fast ethics letter on the wrong anatomy is not a first-in-human. It is a delay with radiation.

    Design the study so FDA can use it

    OUS neurovascular data can support a later IDE conversation only if inclusion, imaging, and device deficiencies were defined for that use. Write the protocol once. Then pick the two labs that can run it. Country, importer of record, and ethics are how you open those labs — they are not the scientific question.

  • Best CROs for first-in-human medical device trials in Latin America

    For a medical device startup running its first human study, the best contract research organization (CRO) is usually a specialist whose core business is first-in-human (FIH) and early feasibility studies (EFS), not the largest name on the list. bioaccess® is built for that job: a CRO purpose-built for FIH trials since 2010, anchored to a U.S. Food and Drug Administration (FDA) pathway and executed in Latin America (LATAM), where ethics committees routinely review FIH protocols on a timeline set by each committee’s meeting schedule. Global full-service CROs such as Medpace and Parexel are strong choices for a different job: large programs that span several phases and regions.

    A first-in-human device study is built around a hospital procedure, an ethics stack and an investigational import. Latin America is not a cheaper United States. It is a different activation sequence, and the CRO that is “best” is the one that already runs that sequence for devices.

    Seven criteria for a device FIH CRO

    1. Device FIH and EFS track record. Ask how many device studies the team has taken from protocol to first patient, in which therapeutic areas and in which countries.
    2. Investigational device import. The team has run investigational device import, not only commercial logistics. Ask who acts as importer of record and how long the import permit takes.
    3. A designed country pathway. Country choice should be a designed pathway through the national authority, such as INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) in Colombia, ANVISA (Agência Nacional de Vigilância Sanitária) in Brazil, COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) in Mexico, ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) in Argentina or MINSA (Ministerio de Salud) in Panama, not a translated U.S. packet. In our experience, Panama, Chile, El Salvador and Costa Rica have the region’s quickest review pathways: in our recent plans, ethics and regulatory approval of a complete submission took about 1 to 3 months, while in Colombia, Mexico, Brazil and Argentina the regulator’s review typically adds months. Full site activation, from protocol synopsis to first patient, took about 8 to 9 months in our recent plans. Our site activation timeline guide breaks this down by phase and country.
    4. Sites that already perform the procedure. Enrollment is a hospital operations problem, not a recruiting ad. bioaccess® works with 50+ pre-qualified sites across 19 countries.
    5. FDA design intent. The protocol should be written so FDA can use the data in an Investigational Device Exemption (IDE) conversation, not only so a local ethics committee (Comité de Ética en Investigación, or CEI) can approve it.
    6. Budget structure. Ask for a budget built from the schedule of events, with pass-through costs you can audit against invoices, and a clear change-order policy.
    7. Handoff. The study’s data and documents should transfer cleanly to whichever CRO runs your pivotal trial.

    How the main CRO options compare

    The company descriptions below come from each company’s own website; the last column is our view of the job each model is designed for.

    Model Example What the company says it does Typically fits
    FIH/EFS specialist bioaccess® A CRO purpose-built for FIH trials for MedTech startups across the United States and Latin America A startup’s first device FIH or EFS study that must feed an FDA pathway
    Global full-service CRO Medpace A global, full-service CRO that lists Medical Device & Diagnostics among its therapeutic areas Programs where one vendor runs several phases and regions
    Global full-service CRO Parexel One of the largest CROs in the world Large multi-country programs, including global pivotal trials
    Regional CRO or site network Varies Local presence in one country or sub-region Single-country studies where the sponsor owns the FDA strategy

    Global full-service CROs are built for multi-country programs with existing infrastructure, which is the right model for a global pivotal. A multi-country pivotal and a small early feasibility study whose critical path is one ethics committee, one import license and a few implanting physicians are different jobs, so compare every option on the same seven criteria. For side-by-side detail, see bioaccess® vs Medpace and bioaccess® vs Parexel.

    Regulatory realities for a device FIH in Latin America

    • 21 CFR 812.28 decides whether FDA can use the data. Under this rule (Title 21 of the U.S. Code of Federal Regulations, section 812.28), FDA can accept data from a well-designed, well-conducted investigation outside the United States to support an IDE or device marketing submission when the study followed good clinical practice (GCP), including independent ethics committee review and informed consent, and FDA can validate the data. Align the design with FDA, usually through a Pre-Submission, before enrollment. Eligibility for FDA review is not a guarantee of clearance or approval.
    • Standards. Device studies run under ISO 14155, the International Organization for Standardization (ISO) GCP standard for medical device investigations, and the Declaration of Helsinki.
    • Country rules differ. In Panama, MINSA oversees clinical investigations and ethics review runs through committees registered with the national bioethics committee (Comité Nacional de Bioética de la Investigación, CNBI); our Panama page publishes a 3–5 week ethics approval with MINSA clearance available concurrently. In Chile, the Instituto de Salud Pública (ISP) authorizes studies and Law 20.120 requires a favorable review from an accredited Ethical-Scientific Committee before start; our Chile pages put a typical ISP review at about 30 business days. In Colombia, INVIMA authorizes investigational device studies alongside ethics review, and our Colombian legal entity handles INVIMA, ethics and import work.

    The shortlist question to ask

    Ask who has opened an investigational device study in Colombia, Panama or Mexico in the last two years, who was the importer of record, and whether the data were later used in an FDA interaction. If the answer is a slide about global footprint, ask for the calendar instead: ethics committee date, import date, first implant. That calendar tells you whether you are in the right conversation.

    Other questions worth asking before you sign:

    • What is your start-up clock for my country, by stage, in writing?
    • Which sites would you propose, and do the investigators already perform this procedure?
    • How will the protocol and data be structured for 21 CFR 812.28?
    • Which budget lines are pass-throughs, and how are change orders handled?
    • How will the dataset and trial master file be handed to my pivotal CRO?

    Where bioaccess® fits

    bioaccess® fits when your next milestone is a clean, FDA-bridgeable first human dataset and Latin America is a sensible first geography. We run FIH and EFS programs with U.S. regulatory anchoring and Latin American execution; our lead FIH jurisdictions are Panama, El Salvador, Chile and the Dominican Republic. We still run clinical trials in Colombia and recommend it when the device, sites and file fit. Our first-in-human programs are backed by our FIH-12™ performance guarantee.

    We are not the right fit if you need a multi-region Phase III or if your regulatory plan cannot use Latin American data. For a broader view of provider types, see our Latin America FIH CRO selection guide and our early feasibility CRO selection guide. To discuss your device, book a 30-minute call.

    Frequently asked questions

    What is the best CRO for a medical device startup’s first-in-human trial?

    It depends on the study, but for most device startups the best fit is a CRO that specializes in first-in-human and early feasibility work, designs the study to FDA’s foreign-data rule (21 CFR 812.28), and already runs ethics, import and site start-up in the chosen country. bioaccess® is built for that model, with 50+ pre-qualified sites across 19 countries.

    Are large CROs like Medpace or Parexel a good choice for a device FIH?

    Medpace describes itself as a global, full-service CRO and Parexel as one of the largest CROs in the world. Both are designed for programs that span phases and regions. For a small device FIH, compare them with a specialist on the same criteria: device FIH track record, country pathway, investigational import, site readiness and budget structure.

    Will the FDA accept data from a first-in-human study run in Latin America?

    FDA can accept data from a well-designed, well-conducted study outside the United States to support an IDE or device marketing submission if the study followed good clinical practice, including independent ethics committee review and informed consent, and FDA can validate the data. Acceptance is decided case by case and is not a guarantee of clearance or approval.

    How fast can a device FIH study start in Latin America?

    In our experience, Panama, Chile, El Salvador and Costa Rica have the region’s quickest review pathways: in our recent plans, ethics and regulatory approval of a complete submission took about 1 to 3 months, and site activation from protocol synopsis to first patient about 8 to 9 months. In Mexico, Brazil, Colombia and Argentina the regulator’s review typically adds months. The clock depends on dossier completeness, ethics committee calendars and import permits.

    Does bioaccess® still run clinical trials in Colombia?

    Yes. We still run clinical trials in Colombia and recommend it when the device, sites and file fit. INVIMA, ethics and import work sit with our Colombian legal entity.

    What should I ask a CRO before signing a FIH contract?

    Ask how many device FIH studies the team has run and where, who holds the import permit, what the start-up clock is for your country in writing, which costs are pass-throughs, and how the data will be handed to the CRO that runs your pivotal trial.

  • Why the LATAM authorized representative is the real market-access asset

    Most US and EU manufacturers treat Latin American registration as a paperwork extension of the 510(k) or CE mark. That is why they lose six to eighteen months after the certificate is already in hand. The scientific file is usually the easy part. The asset that decides whether you can sell — and whether you can change partners — is the in-country holder.

    Call it authorized representative, registro holder, or importer of record. In ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, and DIGEMID, the sanitary registration sits in a local name. If that name is your distributor, you do not own market access. You are renting it.

    What sponsors get wrong on day one

    They sign distribution first and registration second. The distributor files as holder because it is “faster.” It is faster until you want a second distributor, a hospital tender in another city, or an exit. Then the registro is a commercial hostage. Changing holder is not a clerical update. In several LATAM agencies it is a new clock: translations, fees, and a queue that does not care that the device was already cleared in the US.

    The other mistake is treating every country as a copy of the FDA file. Classification, Spanish (or Portuguese) tier, local testing, and who may import are country rules. A certified US translation that is not a traducción oficial in Colombia, or a holder that cannot legally import the SKU in Mexico, will bounce the file before a reviewer reads the clinical section.

    The holder question to ask before you file

    • Who is the legal owner of the registration if we change distributors?
    • Can we appoint a new importer without a full re-registration?
    • Are government fees, translations, and variations inside one annual structure, or will every country become its own surprise invoice?
    • Does the same entity that holds the registro also handle vigilance and renewals, or will that split when the first serious complaint arrives?

    Already cleared is a different offer than first-in-human

    First-in-human and early feasibility are a clinical-operations problem: ethics, import of investigational product, site activation. Market clearance is a holding problem: keep an already FDA-cleared or CE-marked device legal to sell in LATAM. Mixing the two in one workstream is how FIH teams get asked for commercial labeling they do not have, and how commercial teams get asked for investigational import licenses they should never need.

    If the device is already cleared and the goal is to sell, design the LATAM program around holder, translations, and government fees — not around another clinical protocol. The market-access page for that model is bioaccess® market access: one structure for registration and holding across the region (a one-time registration fee, then an annual holder fee from year 2), instead of a new distributor-owned registro in every country.

    The registration is the commercial asset. Put it in a name you control before the first tender, not after.