cms.bioaccessla.com

Blog

  • Is Latin America or Australia cheaper and faster for an early feasibility study?

    Founders keep asking which early-feasibility destination is cheaper and faster: Latin America or Australia. They want a single winner. There is not one.

    I am Julio Martinez-Clark, CEO of bioaccess®. This is the comparison I reuse when a US MedTech team has already heard the Australia CTN story and the LATAM cost story, and needs a decision frame instead of a brochure. It sits next to the live Australia vs Latin America FIH note and the Early Feasibility Studies pillar.

    One-sentence answer

    Latin America is usually cheaper per patient and can be faster to first patient when the dossier, ethics stack, and import plan are built for the country you chose. Australia stays faster to start when you need an English academic workflow and you are not ready to run a Spanish or Portuguese trámite. Neither wins if the protocol cannot support the FDA conversation you need next.

    Cheaper is not the same as lower total cost

    Per-patient cost in Colombia or Panama is often in a planning band about 40–60% below a comparable US or Australian number for similar procedure work. That band is experience-based from bioaccess® programs since 2010 — not a quote for your protocol.

    Total program cost only wins if you do not pay for a second early feasibility study because the first one was exploratory in a way FDA later ignores. A cheaper study that cannot travel into an IDE conversation under 21 CFR 812.28 is a redo, not a savings.

    Faster depends on which clock you mean

    Australia. CTN/CTX and English ethics make the path look short. The CTN is often not the critical path. Site contracting, device import, and hospital activation still stack. Sponsors who budget “12 weeks to first patient in” from a CTN slide routinely discover the bottleneck was logistics.

    Latin America. There is no single LATAM clock. Colombia (INVIMA), Brazil (ANVISA), Mexico (COFEPRIS), Argentina (ANMAT), and Panama (MINSA / CNBI-accredited ethics) have different ethics and regulator stacks. Panama’s ethics-committee-driven pathway for many early device studies can land in a planning band of about 3–5 months from submission to first patient when the file is complete. Colombia’s CEI clock and INVIMA clock are not the same clock. Pick the country before you translate the packet.

    Four filters that decide the winner

    1. Language and dossier. Australia keeps an English core. LATAM usually does not. INVIMA’s traducción oficial is not a certified PDF from a US vendor. Plan translation from the source language on day one.

    2. Ethics vs regulator. In both regions, ethics can move while another gate is still open. In Australia, HREC approval does not mean the site is open. In Colombia, ethics clearance is not INVIMA authorization. In Panama, Decreto Ejecutivo No. 21 of 2026 (Gaceta Oficial No. 30510-C) sets RESEGIS registration and Type II ethics accreditation as process gates — not as a reason to skip import planning.

    3. Import and device custody. A first-in-human implant or catheter does not travel like a pill. Importer of record, customs, and cold chain decide whether first patient slips after every approval is “done.”

    4. FDA usability. Foreign clinical data can support an IDE conversation when protocol, monitoring, and endpoints were written for that use under 21 CFR 812.28 and ISO 14155. Acceptance is still FDA’s call per submission.

    When Australia is the better early-feasibility pick

    Pick Australia when the device already fits an English academic workflow, the implanting volume you need exists there, and your next FDA interaction is weeks away rather than a full year of LATAM build. It is also the better default if you have no in-country regulatory infrastructure in Latin America and you are not willing to build it for this study.

    When Latin America is the better early-feasibility pick

    Pick Latin America when enrollment speed and procedure volume are the constraint — structural heart, neurovascular, and other high-volume hospital procedures — and you will treat INVIMA, ANVISA, COFEPRIS, or Panama’s CNBI-accredited pathway as a designed pathway instead of a translated Australian packet. It is also the better default when you already need a LATAM authorized representative or in-country holder for a later commercial filing. Trial import and later registro are different trámites; they reward the same discipline.

    The mistake that burns both options

    Copying a US protocol, swapping the letterhead, and calling it an OUS early feasibility study. Australia will make that look viable longer than it is. Latin America will often reject it earlier on a form or a translation, which feels slower and is usually cheaper than discovering after 20 patients that the protocol cannot support the IDE.

    Write the protocol for the data you need FDA to accept. Then pick the country whose ethics, import, and site-activation calendar can deliver that protocol. The region is a tactic. The evidence plan is the strategy.

    Talk with bioaccess® when you need the Australia-vs-LATAM call tied to a concrete early feasibility country plan and an FDA-anchored evidence drawer. Market-access work after the trial is a separate path on our market access page.

  • Does Panama require functional large-animal studies for a medical device FIH?

    Sponsors planning a Panama first-in-human (FIH) medical-device study keep asking the same yes/no question: does MINSA require a functional large-animal study before ethics or Ministry review will move?

    I am Julio Martinez-Clark, CEO of bioaccess®. Short answer: no. Functional large-animal studies are not a hard, across-the-board MINSA requirement for a Panama FIH device study. The longer answer is what you need for the dossier.

    This note sits next to our live Decreto 21 of 2026 explainer and the Panama FIH device guide. It is operator guidance, not legal advice and not a quote.

    One-sentence answer

    Panama’s current clinical-research rulebook sets process and documentation. It does not publish a required animal n, species, or duration for investigational medical devices. On quality standard, Decreto Ejecutivo 21 of 2026, Art. 102, says preclinical studies, when necessary, must follow Good Laboratory Practice (GLP). MINSA’s research office (URIS) confirmed in October 2026 that this applies to preclinical studies performed in Panama. Preclinical studies done abroad do not need to be repeated locally; they must be included in the investigator’s brochure, follow recognized standards, and are assessed by the ethics committee. Formal questions to MINSA go by letter or email to URIS, copying the Dirección General de Salud Pública, not through RESEGIS.

    What the rulebook actually says

    Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C) implements Titles III and IV of Ley 84 of 14 May 2019. For sponsors, the decree turns on three operational gates:

    • Registration on RESEGIS (MINSA’s national research-registration platform) before execution begins
    • Ethics review by a committee accredited by the CNBI (Comité Nacional de Bioética de la Investigación)
    • For higher-risk protocols, MINSA registration plus technical/public-health evaluation via RESEGIS, with ethics review by the accredited committee — which may run in parallel where the committee permits it

    The decree also defines the documentation package — protocol, investigator’s brochure (IB), informed consent, insurance, and related files. The protocol is submitted in Spanish. It does not set a preclinical animal checklist.

    What MINSA and the CNBI-accredited committee actually review

    Reviewers look for a coherent risk-benefit narrative, not a species count. In practice that means:

    • ISO 10993 biocompatibility evidence that is scientifically valid for the contact and duration you claim (GLP under Art. 102 of Decreto Ejecutivo 21 if the studies are performed in Panama; studies done abroad must follow recognized standards and appear in the investigator’s brochure)
    • Mechanical and functional bench data that match the intended use
    • Sterilization and packaging evidence for the investigational configuration
    • An ISO 14971 risk file that ties residual risks to the first-in-human cohort
    • An IB that documents the safety information you actually have

    When the device class, contact duration, or mechanism warrants animal data, that data goes in the narrative. Animal work is a conditional element of the risk story. It is not a statute that says “run a porcine efficacy study or stop.”

    How this differs from a class-specific scientific frame

    Some device classes commonly use large-animal models with functional outcomes, histology, and imaging correlation — for example certain injectable or implant programs where the science community expects that evidence. Treat those models as a scientific frame for that class, not as a Panama statute. Confusing the two is how teams overbuild the wrong study or underbuild the IB.

    What did not get stricter after Decreto 21

    Decreto 21 of 2026 tightened process: ethics accreditation, RESEGIS registration, defined review clocks, and — for high-risk protocols — parallel ethics review where the accredited committee permits it. It did not invent a new large-animal efficacy mandate.

    Operator checklist before you ask for a Panama dictamen

    1. Write one page that states what preclinical evidence you have and what residual risk it leaves for first-in-human use.
    2. Map each residual risk to a control in the protocol (cohort size, stopping rules, imaging, monitoring).
    3. Confirm the IB and ISO 14971 file tell the same story in Spanish for the CNBI-accredited committee.
    4. Register the study in RESEGIS before execution; do not treat ethics approval as a substitute for registration.
    5. If you already have an animal study (or a deliberate gap), ask whether that study closes a risk the IB claims — not whether Panama “requires animals.”

    Talk with bioaccess® when you need the Panama FIH dossier framed for CNBI and MINSA without inventing a statute that is not in Decreto 21.

  • Medical Device Regulatory Consulting: When to Hire a Specialist

    Medical Device Regulatory Consulting: When to Hire a Specialist

    WordPress Category: Navigating Regulatory Landscapes in Latin America

    Medical device regulatory consulting sits at the intersection of science, law, and clinical strategy — and knowing when to bring in a specialist can determine whether your program reaches first-in-human data on schedule or stalls for a year waiting on approvals. For startup founders and CSOs managing a $1M to $5M FIH budget, that distinction is not academic. It is the difference between hitting an investor milestone and missing it.

    This article maps out the decision points where specialist regulatory guidance pays for itself, what to look for in a consultant versus a full-service CRO, and how the regulatory consulting function fits inside a broader FIH execution strategy.

    What Medical Device Regulatory Consulting Actually Covers

    Regulatory consulting for medical devices is not a single service. It spans at least five distinct functional areas, and most sponsors need different combinations depending on their stage.

    Pre-submission strategy. Before you file anything with the FDA, a Pre-Sub (formerly Pre-IDE) meeting can clarify the agency's expectations on study design, endpoints, and the evidence threshold for an IDE or 510(k). A regulatory consultant helps you structure that meeting, draft the questions, and interpret the FDA's written response in a way that shapes your protocol — not just files it away.

    IDE and IND pathway navigation. For investigational devices, the IDE application is the gateway to human studies in the United States. A consultant maps out whether your device requires a significant-risk or non-significant-risk determination, what the IDE application must contain, and how study design decisions made now will affect your eventual 510(k) or PMA submission.

    Protocol and study design alignment. The protocol is not just a clinical document — it is a regulatory artifact. Every endpoint, inclusion criterion, and follow-up interval either supports or complicates your future submission. Regulatory consultants who understand FDA expectations can pressure-test a protocol before it reaches an Ethics Committee (EC) or Institutional Review Board (IRB).

    International regulatory dossier preparation. If your FIH study will run outside the United States — in Colombia, Panama, Chile, or another Latin American market — you need country-specific regulatory dossiers. INVIMA in Colombia, MINSA/CNBI in Panama, and ISP/MINSAL in Chile each have distinct submission requirements. A consultant with in-country experience knows what each authority expects and how to sequence submissions to avoid delays.

    Post-market and registration strategy. Once a device is FDA-cleared or CE-marked, entering Latin American markets requires separate registrations with ANVISA (Brazil), COFEPRIS (Mexico), ANMAT (Argentina), DIGEMID (Peru), and others. This is a distinct regulatory workstream from clinical trial approval, and it requires a different kind of specialist.

    The Four Moments That Signal You Need a Specialist

    Most MedTech startups underestimate how early regulatory consulting should begin. The four clearest triggers are:

    1. You Are Approaching Design Freeze

    Design freeze is the point at which your device's specifications are locked for verification and validation. Changes after that point carry significant regulatory cost. A regulatory consultant engaged before design freeze can confirm that your intended indication, device classification, and predicate strategy are coherent — before the engineering team locks anything in.

    Waiting until after design freeze to engage regulatory counsel is one of the most common and expensive mistakes in early-stage MedTech development.

    2. You Are Preparing a Pre-Sub or IDE Application

    The FDA Pre-Sub process is structured but not simple. A poorly framed Pre-Sub question can produce a response that is technically accurate but operationally unhelpful. A specialist knows how to frame questions so the agency's answers give you actionable guidance on study design, sample size, and endpoint selection.

    For IDE applications, the consultant's role is to ensure the application is complete, that the risk analysis is defensible, and that the clinical protocol meets 21 CFR 812 requirements. An incomplete IDE triggers a deficiency letter — and that can add months to your timeline.

    3. Your FIH Study Will Run in Latin America

    Running a first-in-human study in Latin America requires regulatory expertise that most US-based consultants do not carry. Each country's health authority has its own submission format, language requirements, and review timelines. Ethics Committee approvals and ministry-of-health approvals to conduct the studies are separate processes that must be sequenced correctly.

    In Panama, El Salvador, Chile, and the Dominican Republic, ethics and regulatory approvals are observed in 30 to 90 days when submissions are prepared correctly. That speed advantage disappears quickly if the dossier is incomplete or formatted incorrectly for the receiving authority.

    This is where the distinction between a pure regulatory consultant and a full-service CRO becomes important. A consultant can prepare the dossier. A CRO with in-country regulatory infrastructure can prepare the dossier, manage the submission, respond to authority queries, and activate the clinical site — all within the same accountability structure.

    4. You Are Preparing for Market Registration After FDA Clearance

    If your device has received 510(k) clearance or PMA approval and you are targeting Latin American markets, you need a specialist in each country's registration process. ANVISA's registration pathway in Brazil differs substantially from COFEPRIS in Mexico or INVIMA in Colombia. Timelines, required documentation, and in-country holder requirements vary by country and device class.

    Attempting these registrations without country-specific expertise typically results in incomplete submissions, requests for additional information, and delays that push market entry back by 12 to 18 months.

    Regulatory Consultant vs. Full-Service CRO: Where the Line Is

    A regulatory consultant advises. A full-service CRO executes. For early-stage sponsors, the practical question is which one your program actually needs at a given point.

    A standalone regulatory consultant is appropriate when your primary need is strategic guidance: Pre-Sub preparation, IDE pathway analysis, classification review, or a gap assessment of your technical file. The output is a document or a recommendation. Execution stays with your internal team.

    A full-service CRO with regulatory capabilities is appropriate when execution is the bottleneck. If you need regulatory dossiers filed in three countries, Ethics Committee submissions managed, sites activated, patients enrolled, and data collected to ISO 14155 and FDA 21 CFR 812.28 standards — all within a 12-month window — a consultant relationship is structurally insufficient. You need a team that owns the process end to end.

    The risk of using a consultant when you need a CRO is diffuse accountability. The consultant delivers a strategy document. Who files the INVIMA submission? Who manages the EC query response? Who ensures the data management system produces an FDA-submissible dataset? When those questions have no clear owner, timelines slip.

    What FDA Data Bridging Requires from Your Regulatory Setup

    A common concern among US-based sponsors considering OUS early clinical studies is whether data collected outside the United States will hold up with the FDA. The answer depends entirely on how the study is structured and documented.

    Data collected under ISO 14155 and structured per FDA 21 CFR 812.28 is accepted for US IDE and IND submissions. That is not a LatAm-specific rule — it is the standard the FDA applies to any international clinical data submitted in support of a US application. The regulatory consultant or CRO you engage must have explicit experience building evidence packages to this standard, not just running compliant trials in their home jurisdiction.

    This is a non-negotiable qualification when evaluating regulatory partners for an OUS FIH study. Ask specifically: has the team prepared an FDA-submissible evidence package from a LatAm study? What was the submission type, and what was the FDA's response?

    How bioaccess® Integrates Regulatory Consulting Into FIH Execution

    bioaccess® operates as a Miami-headquartered CRO with a site network spanning more than 50 pre-qualified sites across 19 Latin American and Caribbean markets. The FIH-12™ program structures regulatory execution as one of nine workstreams inside a 12-month engagement — covering FDA Pre-Sub and IDE/IND pathway alignment, country-specific dossier preparation, Ethics Committee submissions, and ministry-of-health approvals to conduct the studies.

    The regulatory workstream does not operate in isolation. Protocol development, site activation, patient enrollment, data management, and submission-ready evidence package delivery are managed by the same team. That single-team accountability model addresses the diffuse accountability problem that arises when regulatory consulting and clinical execution are split across separate vendors.

    For sponsors who have already achieved FDA clearance or CE marking, the LATAM Launch Subscription provides in-country holder and Importer of Record registration across ANVISA, INVIMA, COFEPRIS, ANMAT, ISP (Chile), DIGEMID (Peru), and other regional authorities — a distinct regulatory workstream managed through the same operational infrastructure.

    The Cook Group program illustrates what integrated regulatory execution looks like at scale. In the multi-site first-in-human artificial venous valve study in Colombia, bioaccess® managed more than 142 INVIMA regulatory submissions across a complex multi-site engagement. That volume of regulatory activity requires more than advisory capacity — it requires in-country infrastructure and dedicated regulatory operations staff.

    ClarVista Medical's program demonstrates how regulatory execution inside a structured FIH engagement can support a commercial outcome. The ClarVista first-in-human program in Latin America produced the clinical evidence that supported the company's eventual acquisition by Alcon. The regulatory pathway was built to produce FDA-bridgeable data from the outset.

    For sponsors at the market-registration stage, the CryoConcepts COFEPRIS registration program in Mexico shows how a structured in-country regulatory engagement handles the Histafreezer STAT device registration and regulatory transition — a process that requires country-specific expertise that general regulatory consultants rarely carry.

    Questions to Ask Before Engaging Any Regulatory Specialist

    Before signing an engagement with a regulatory consultant or CRO, these questions will surface gaps in capability or fit:

    • Have you prepared regulatory dossiers for submission to INVIMA, MINSA/CNBI, ISP/MINSAL, or other LatAm authorities? For what device types?
    • Can you produce an evidence package structured to FDA 21 CFR 812.28 from an OUS study? What submissions have you supported with that package?
    • Who owns the regulatory submission process end to end — the consultant, a subcontractor, or in-country staff?
    • What is your observed timeline for ethics and ministry-of-health approvals in the countries you operate in?
    • How do you handle authority queries during the review period? What is your average response time?
    • Do you have experience with the specific device classification or indication relevant to our program?

    The answers will tell you whether you are engaging an advisor or an operator — and whether that distinction matters for your current stage.

    Regulatory Consulting Across the Device Development Lifecycle

    Regulatory consulting needs shift as a device program matures. A rough map:

    Pre-clinical to IDE-ready: Classification review, Pre-Sub strategy, IDE application preparation, protocol pressure-testing against FDA expectations.

    IDE-approved to FIH: Country selection for OUS studies, regulatory dossier preparation, Ethics Committee submissions, ministry-of-health approvals, site qualification.

    FIH data to US submission: Evidence package structuring to 21 CFR 812.28 and ISO 14155, FDA Pre-Sub follow-up, IDE supplement or 510(k)/PMA preparation.

    Post-clearance to LatAm market entry: ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID registrations, in-country holder designation, Importer of Record setup.

    Each phase requires a different depth of regulatory expertise. A consultant who is strong on Pre-Sub strategy may have no infrastructure for INVIMA submissions. A CRO strong in FIH execution may not carry the post-market registration capability you need 18 months later.

    The Envveno Medical program illustrates this lifecycle in practice. The LATAM FIH execution built the clinical foundation that supported the first-ever FDA IDE for a non-surgical replacement venous valve. Regulatory strategy and clinical execution were not separate workstreams — they were built together from the start.

    Frequently Asked Questions

    What does a medical device regulatory consultant do?
    A medical device regulatory consultant advises sponsors on FDA classification, Pre-Sub strategy, IDE and 510(k) pathway selection, and international regulatory dossier requirements. The scope is advisory; execution typically remains with the sponsor's internal team or a CRO.

    When should a MedTech startup hire a regulatory consultant?
    The clearest triggers are approaching design freeze, preparing a Pre-Sub or IDE application, planning an OUS first-in-human study, or preparing for market registration in Latin American countries after FDA clearance. Engaging before design freeze is almost always more cost-effective than engaging after.

    What is the difference between a regulatory consultant and a CRO?
    A regulatory consultant provides strategic guidance and prepares documents. A CRO executes the clinical and regulatory program — filing submissions, managing Ethics Committee and ministry-of-health approvals, activating sites, enrolling patients, and delivering a submission-ready evidence package. When execution is the bottleneck, a CRO with integrated regulatory capability is the appropriate choice.

    Will data from a Latin American FIH study be accepted by the FDA?
    Data collected under ISO 14155 and structured per FDA 21 CFR 812.28 is accepted for US IDE and IND submissions. The study must be designed and documented to those standards from the outset — this is not automatic. It requires a regulatory partner with explicit experience building FDA-submissible evidence packages from OUS studies.

    How long do regulatory approvals take in Latin American countries?
    In Panama, El Salvador, Chile, and the Dominican Republic, ethics and regulatory approvals are observed in 30 to 90 days when submissions are prepared correctly. These are observed ranges, not guarantees, and they depend on complete, correctly formatted dossiers submitted to the right authorities in the right sequence.

    What regulatory bodies govern medical device trials in Latin America?
    Key authorities include INVIMA (Colombia), MINSA/CNBI (Panama), ISP/MINSAL (Chile), SRS/CNEIS (El Salvador), ANVISA (Brazil), COFEPRIS (Mexico), ANMAT (Argentina), and DIGEMID (Peru). Each has distinct submission requirements, review timelines, and in-country holder rules.

    Can a single partner handle both FIH regulatory execution and post-market registration in Latin America?
    Yes, if the partner has both clinical trial infrastructure and post-market registration capability across the relevant countries. bioaccess® covers both through the FIH-12™ program for clinical execution and the LATAM Launch Subscription for in-country holder and Importer of Record registration across ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID, and other regional authorities.

    The Right Specialist at the Right Stage

    Medical device regulatory consulting is not a single engagement type. It is a set of capabilities that your program needs at different intensities across the development lifecycle. The question is not whether to hire a specialist — it is which kind, at which stage, and with what accountability structure.

    For programs at the FIH stage targeting Latin American execution, the regulatory workstream cannot be separated from clinical operations without creating accountability gaps that cost time and capital. The sponsor's financial runway rarely accommodates those gaps.

    To understand how bioaccess® structures regulatory execution inside a 12-month FIH program, visit bioaccessla.com.

  • First-in-Human Medical Device Trials in Austria

    Austria is a smaller early device market in our data, but most of its work comes from foreign sponsors and multinational programs. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the public registry shows, and how Austria compares with Latin America for a United States (US) sponsor.

    What the registry shows

    Our query of ClinicalTrials.gov (CT.gov) found 33 early-stage, industry-sponsored device studies with at least one site in Austria, first posted between 1 January 2021 and 28 September 2026. That ranks Austria #21 worldwide on this measure. Of these, 18 used FIH, feasibility or pilot language in the title or summary, and 4 explicitly described a first-in-human or early feasibility study. 21 were run by sponsors headquartered outside Austria, 9 of them by US-headquartered companies, and 18 also listed sites in another country. Registrations went from 20 in 2021–2023 to 13 from January 2024 to September 2026.

    Method: bioaccess® analysis of the ClinicalTrials.gov (CT.gov) application programming interface (API) v2, run 28 September 2026: industry-sponsored interventional device studies first posted 1 January 2021 to 28 September 2026 (6,045). Early-stage means FIH, early feasibility, feasibility or pilot wording, or phase N/A with 50 or fewer planned participants (2,968 worldwide). Sponsor headquarters were inferred for 95% of studies. Counts are registrations, not approvals, and recent years are under-counted.

    How authorization works in Austria

    Austria applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745) through the Medical Devices Act 2021 (Medizinproduktegesetz, MPG 2021). Applications go to the Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG).

    • Electronic submission only.
    • Ethics first: the application must include a final, favourable ethics committee vote. BASG does not accept a preliminary vote, and an application without a final vote will be rejected.
    • Validation: within 10 days, BASG confirms the application is valid or sends a deficiency letter. The sponsor has 10 days to respond, or 20 more on justified request, and BASG then completes validation within 5 days.
    • Start: investigations under Art. 70(7)(a) MDR (class I and non-invasive class IIa/IIb) may start after BASG confirms validation. Investigations under Art. 70(7)(b), which covers most FIH devices, need a 45-day review, extendable by 20 days for experts.
    • Sponsors based outside the EU need an EU legal representative (Art. 62(2) MDR).

    Where Austria is strong

    • Foreign and multinational use: 21 of 33 early studies came from sponsors headquartered outside Austria, and 18 had sites in other countries.
    • Feasibility-oriented: 18 studies (55%) described themselves as FIH, feasibility or pilot studies.
    • A clear procedure: BASG publishes step-by-step validation timelines and uses electronic submission only.
    • Therapeutic focus: Cardiovascular (13 studies), neurology (5) and respiratory (5) led the mix.

    Austria’s numbers are small, so the change between periods (20 to 13) should be read with caution.

    Using data from Austria in a US submission

    The US Food and Drug Administration (FDA) can accept device data from outside the United States under the Code of Federal Regulations (CFR) at 21 CFR 812.28 if the study follows good clinical practice (GCP), including independent ethics review and informed consent, the sponsor supplies the required supporting information, and FDA can validate the data, if needed by inspection. The rule covers studies begun on or after 21 February 2019. FDA recognizes the International Organization for Standardization (ISO) device GCP standard, ISO 14155:2020; check the recognition status of the 2026 edition before you plan to it. Meeting 812.28 is not clearance or approval, and FDA may still ask for US data. Confirm your plan through a pre-submission under FDA’s Q-Submission (Q-Sub) program.

    How Latin America compares

    Austria requires the final ethics vote before BASG review, and Vienna is six hours ahead of US Eastern for most of the year. Across the 15 Latin American countries we track, the same query found 132 early-stage device studies in total. 38 of them were explicitly FIH or EFS, which is 12% of the 310 such studies worldwide, and 102 (77%) had US-headquartered sponsors. The region is used mainly for US companies’ first human data.

    • Time zone: Panama stays on UTC−5 (Coordinated Universal Time minus five) all year, the same as US Eastern Standard Time.
    • Regulation: each Latin American country has its own national pathway. We don’t quote a single clock; country planning ranges come with each proposal.
    • Ethics: bioaccess® publishes a 4–8 week median planning range for ethics review in its lead countries. This is based on our experience, not a formal study, and it is not a guarantee.
    • Cost: we don’t publish per-patient figures. Compare line-item budgets, including monitoring travel and translation.
    • Where we work: bioaccess® has focused on FIH studies since 2010. We lead execution in Panama, El Salvador, Chile and the Dominican Republic, with 50+ pre-qualified sites across 19 countries.

    When Austria is the better fit: as a site in a multinational European program, or when specific Austrian investigators are central to your device. For a standalone FIH study aimed at FDA, compare a Latin American site on time zone, enrollment and travel.

    Frequently asked questions

    Do I need ethics approval before applying to BASG?

    Yes. The application must include a final, favourable ethics vote. BASG rejects applications with only a preliminary vote.

    How long does BASG take?

    BASG confirms validity or sends a deficiency letter within 10 days. Class I and non-invasive IIa/IIb investigations may start after validation, and other classes need a 45-day review, plus 20 days if experts are consulted.

    Which law governs device investigations in Austria?

    The EU MDR, together with the Austrian Medical Devices Act 2021 (MPG 2021).

    Can data from an Austrian first-in-human study support an FDA submission?

    Yes, if the study meets 21 CFR 812.28 and FDA can validate the data. That makes the data reviewable. It is not clearance or approval.

    Next step

    Weighing Austria against Latin America for an FIH or EFS study? Book a call with Julio Martinez-Clark to review your device class, endpoints and FDA plan.

    Sources

  • First-in-Human Medical Device Trials in China

    China is the only one of the ten busiest countries in our data where early device study registrations rose sharply, but the work is mostly domestic. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is regulated there, what the registry shows, and what that means for a United States (US) sponsor weighing China against Latin America.

    What the registry shows

    Our query of ClinicalTrials.gov (CT.gov) found 108 early-stage, industry-sponsored device studies with at least one site in China, first posted between 1 January 2021 and 28 September 2026. That ranks China #7 worldwide on this measure. Of these, 49 used FIH, feasibility or pilot language in the title or summary, and 22 explicitly described a first-in-human or early feasibility study. 17 were run by sponsors headquartered outside China, 11 of them by US-headquartered companies, and 3 also listed sites in another country. Registrations went from 47 in 2021–2023 to 61 from January 2024 to September 2026. Sponsor headquarters could not be resolved for 11 studies, so the home-country count is a floor.

    Method: bioaccess® analysis of the ClinicalTrials.gov (CT.gov) application programming interface (API) v2, run 28 September 2026: industry-sponsored interventional device studies first posted 1 January 2021 to 28 September 2026 (6,045). Early-stage means FIH, early feasibility, feasibility or pilot wording, or phase N/A with 50 or fewer planned participants (2,968 worldwide). Sponsor headquarters were inferred for 95% of studies. Counts are registrations, not approvals, and recent years are under-counted.

    How device trials are regulated in China

    Device trials in China follow the Provisions for Medical Device Registration and Filing (State Administration for Market Regulation (SAMR) Decree No. 47, effective 1 October 2021), administered by the National Medical Products Administration (NMPA).

    • Filed sites and good clinical practice: trials must follow device good clinical practice (GCP) at qualified institutions that have filed with the authorities, and each trial is filed with the provincial regulator (Art. 37).
    • High-risk class III devices: devices on NMPA’s catalogue need NMPA approval before the trial and must be studied in top-tier (tertiary grade A) hospitals (Art. 38). NMPA decides within 60 days of accepting the application, and the result is published through its Center for Medical Device Evaluation (CMDE). If NMPA does not respond in time, the trial counts as approved (Art. 40).
    • Overseas companies need a legal agent in China (Art. 14).
    • Human genetic resources (HGR): under China’s 2019 HGR regulations, foreign entities may not collect or store Chinese human genetic resources themselves or send them abroad. Work involving such material needs Chinese partners, the relevant approvals or filings, and ethics review. Plan for this if your study collects biological samples.

    Where China is strong

    • Growth: the only sharp rise in registrations among the ten countries with the most studies (about +42% annualized).
    • FIH volume: 22 of 108 studies were explicitly FIH or EFS, more than any European country we profiled.
    • Cardiovascular scale: Cardiovascular (63 studies), oncology (15) and neurology (10) led the mix, and cardiovascular alone made up more than half.

    Using data from China in a US submission

    The US Food and Drug Administration (FDA) can accept device data from outside the United States under the Code of Federal Regulations (CFR) at 21 CFR 812.28 if the study follows good clinical practice (GCP), including independent ethics review and informed consent, the sponsor supplies the required supporting information, and FDA can validate the data, if needed by inspection. The rule covers studies begun on or after 21 February 2019. FDA recognizes the International Organization for Standardization (ISO) device GCP standard, ISO 14155:2020; check the recognition status of the 2026 edition before you plan to it. Meeting 812.28 is not clearance or approval, and FDA may still ask for US data. Confirm your plan through a pre-submission under FDA’s Q-Submission (Q-Sub) program.

    How Latin America compares

    China’s early device work is overwhelmingly domestic (80 of 108 studies had Chinese-headquartered sponsors), and China is 12 hours ahead of US Eastern during US daylight saving time and 13 otherwise. Across the 15 Latin American countries we track, the same query found 132 early-stage device studies in total. 38 of them were explicitly FIH or EFS, which is 12% of the 310 such studies worldwide, and 102 (77%) had US-headquartered sponsors. The region is used mainly for US companies’ first human data.

    • Time zone: Panama stays on UTC−5 (Coordinated Universal Time minus five) all year, the same as US Eastern Standard Time.
    • Regulation: each Latin American country has its own national pathway. We don’t quote a single clock; country planning ranges come with each proposal.
    • Ethics: bioaccess® publishes a 4–8 week median planning range for ethics review in its lead countries. This is based on our experience, not a formal study, and it is not a guarantee.
    • Cost: we don’t publish per-patient figures. Compare line-item budgets, including monitoring travel and translation.
    • Where we work: bioaccess® has focused on FIH studies since 2010. We lead execution in Panama, El Salvador, Chile and the Dominican Republic, with 50+ pre-qualified sites across 19 countries.

    When China is the better fit: if the Chinese market is your first commercial target, you have a Chinese partner and legal agent, and your data plan fits the HGR rules. For a US company whose first goal is FDA, Latin America offers a US-aligned time zone and a long record with US sponsors.

    Frequently asked questions

    Does a first-in-human device trial in China need NMPA approval?

    High-risk class III devices on NMPA’s catalogue need NMPA approval, decided within 60 days of acceptance, and must be studied in tertiary grade A hospitals. Other trials are filed with the provincial regulator and run at filed, qualified institutions under GCP.

    Can a foreign company run a device trial in China directly?

    Overseas companies need a legal agent in China. Under the 2019 human genetic resources regulations, foreign entities also may not collect or store Chinese human genetic resources themselves or send them abroad.

    Can data from a Chinese first-in-human study support an FDA submission?

    It can, if the study meets 21 CFR 812.28 and FDA can validate the data, including by inspection. Sample-export limits under China’s HGR rules may affect what can be verified outside China. Acceptance is not clearance or approval.

    How does China compare with Latin America for a US sponsor’s first-in-human study?

    China has volume and growth, mostly for domestic sponsors, 12–13 hours from US Eastern. Latin American sites work mainly with US sponsors, and Panama keeps US Eastern Standard Time all year.

    Next step

    Weighing China against Latin America for an FIH or EFS study? Book a call with Julio Martinez-Clark to review your device class, endpoints and FDA plan.

    Sources

  • First-in-Human Device Trials in the Netherlands

    The Netherlands has a smaller early device study count than its neighbors, but a high share of feasibility-style work and heavy use by foreign sponsors. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is submitted there, what the registry shows, and how Latin America compares for a United States (US) sponsor.

    What the registry shows

    Our query of ClinicalTrials.gov (CT.gov) found 58 early-stage, industry-sponsored device studies with at least one site in the Netherlands, first posted between 1 January 2021 and 28 September 2026. That ranks the Netherlands #13 worldwide on this measure. Of these, 32 used FIH, feasibility or pilot language in the title or summary, and 6 explicitly described a first-in-human or early feasibility study. 44 were run by sponsors headquartered outside the Netherlands, 19 of them by US-headquartered companies, and 29 also listed sites in another country. Registrations went from 33 in 2021–2023 to 25 from January 2024 to September 2026.

    Method: bioaccess® analysis of the ClinicalTrials.gov (CT.gov) application programming interface (API) v2, run 28 September 2026: industry-sponsored interventional device studies first posted 1 January 2021 to 28 September 2026 (6,045). Early-stage means FIH, early feasibility, feasibility or pilot wording, or phase N/A with 50 or fewer planned participants (2,968 worldwide). Sponsor headquarters were inferred for 95% of studies. Counts are registrations, not approvals, and recent years are under-counted.

    How submission works in the Netherlands

    The Netherlands applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745). The Central Committee on Research Involving Human Subjects (Centrale Commissie Mensgebonden Onderzoek, CCMO) runs the process through its Research Portal.

    • Investigations for conformity assessment (MDR Articles 62 and 74(2), which covers most FIH studies): CCMO validates the research file first. It then passes the file to the review committee the sponsor chose, either an accredited medical research ethics committee (MREC) or the CCMO itself.
    • Other investigations (Articles 74(1) and 82) go straight to the chosen MREC.
    • Required files: CCMO’s standard research file for devices lists what to submit, including an EUDAMED (European Database on Medical Devices) form and the investigational device dossier.
    • Timelines: investigations under Article 62 follow the MDR’s Article 70 clocks (validation, then 45 days for invasive class IIa, IIb and III devices, plus 20 days for experts). Sponsors based outside the EU need an EU legal representative (Art. 62(2) MDR).

    Where the Netherlands is strong

    • Feasibility-heavy: 32 of 58 early studies (55%) described themselves as FIH, feasibility or pilot studies, one of the highest shares in our data.
    • Foreign sponsors: 44 studies came from sponsors headquartered outside the country, including 19 US-headquartered companies, and 29 had sites in other countries.
    • One portal: CCMO’s Research Portal handles validation and routing.
    • Therapeutic depth: Cardiovascular (13 studies), orthopedic and spine (8) and respiratory (7) led the mix.

    Using data from the Netherlands in a US submission

    The US Food and Drug Administration (FDA) can accept device data from outside the United States under the Code of Federal Regulations (CFR) at 21 CFR 812.28 if the study follows good clinical practice (GCP), including independent ethics review and informed consent, the sponsor supplies the required supporting information, and FDA can validate the data, if needed by inspection. The rule covers studies begun on or after 21 February 2019. FDA recognizes the International Organization for Standardization (ISO) device GCP standard, ISO 14155:2020; check the recognition status of the 2026 edition before you plan to it. Meeting 812.28 is not clearance or approval, and FDA may still ask for US data. Confirm your plan through a pre-submission under FDA’s Q-Submission (Q-Sub) program.

    How Latin America compares

    The Dutch process routes studies through one portal and one chosen committee, and Amsterdam is six hours ahead of US Eastern for most of the year. Across the 15 Latin American countries we track, the same query found 132 early-stage device studies in total. 38 of them were explicitly FIH or EFS, which is 12% of the 310 such studies worldwide, and 102 (77%) had US-headquartered sponsors. The region is used mainly for US companies’ first human data.

    • Time zone: Panama stays on UTC−5 (Coordinated Universal Time minus five) all year, the same as US Eastern Standard Time.
    • Regulation: each Latin American country has its own national pathway. We don’t quote a single clock; country planning ranges come with each proposal.
    • Ethics: bioaccess® publishes a 4–8 week median planning range for ethics review in its lead countries. This is based on our experience, not a formal study, and it is not a guarantee.
    • Cost: we don’t publish per-patient figures. Compare line-item budgets, including monitoring travel and translation.
    • Where we work: bioaccess® has focused on FIH studies since 2010. We lead execution in Panama, El Salvador, Chile and the Dominican Republic, with 50+ pre-qualified sites across 19 countries.

    When the Netherlands is the better fit: for feasibility studies that need EU data under the MDR, with sites used to foreign sponsors. For the very first implant, compare a Latin American option on time zone and on how easily the US team can attend.

    Frequently asked questions

    Who reviews device investigations in the Netherlands?

    For investigations under MDR Articles 62 and 74(2), CCMO validates the file and passes it to the review committee the sponsor chose: an accredited MREC or the CCMO. Other investigations go directly to an MREC.

    How do I submit a device study in the Netherlands?

    Through CCMO’s Research Portal, using CCMO’s standard research file for medical devices, which includes an EUDAMED form.

    How long does review take?

    Investigations under Article 62 follow the MDR’s Article 70 clocks: validation, then 45 days for invasive class IIa, IIb and III devices, plus 20 days for experts. We do not quote a Dutch median.

    Can data from a Dutch first-in-human study support an FDA submission?

    Yes, if the study meets 21 CFR 812.28 and FDA can validate the data. That makes the data reviewable. It is not clearance or approval.

    Next step

    Weighing the Netherlands against Latin America for an FIH or EFS study? Book a call with Julio Martinez-Clark to review your device class, endpoints and FDA plan.

    Sources

  • First-in-Human Medical Device Trials in Italy

    Italy ranks fifth worldwide in our count of early-stage device studies and has a large domestic device industry. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the public registry shows, and how Italy lines up against Latin America for a United States (US) sponsor.

    What the registry shows

    Our query of ClinicalTrials.gov (CT.gov) found 116 early-stage, industry-sponsored device studies with at least one site in Italy, first posted between 1 January 2021 and 28 September 2026. That ranks Italy #5 worldwide on this measure. Of these, 42 used FIH, feasibility or pilot language in the title or summary, and 10 explicitly described a first-in-human or early feasibility study. 46 were run by sponsors headquartered outside Italy, 19 of them by US-headquartered companies, and 33 also listed sites in another country. Registrations went from 64 in 2021–2023 to 52 from January 2024 to September 2026.

    Method: bioaccess® analysis of the ClinicalTrials.gov (CT.gov) application programming interface (API) v2, run 28 September 2026: industry-sponsored interventional device studies first posted 1 January 2021 to 28 September 2026 (6,045). Early-stage means FIH, early feasibility, feasibility or pilot wording, or phase N/A with 50 or fewer planned participants (2,968 worldwide). Sponsor headquarters were inferred for 95% of studies. Counts are registrations, not approvals, and recent years are under-counted.

    How authorization works in Italy

    Italy applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745). The regulator for device investigations is the Ministry of Health (Ministero della Salute).

    • Regulator: before a pre-market investigation starts, the sponsor applies to the Ministry of Health under Article 70 of the MDR. For invasive class IIa, IIb and III devices, the MDR allows 45 days from validation, plus 20 days for expert consultation, with the clock stopped during questions.
    • Ethics: one ethics opinion is issued nationally and covers all participating sites, according to the Careggi ethics committee’s instructions.
    • Language and paperwork: the Careggi committee asks for the synopsis, labels, instructions for use and insurance documents in Italian. A sponsor based outside the EU must declare its EU legal representative (Art. 62(2) MDR).

    The Ministry’s own device-investigation page was not reachable when we checked, so confirm current forms with the Ministry before you submit.

    Where Italy is strong

    • A domestic manufacturing base: 67 of 116 early studies were sponsored by Italian-headquartered companies.
    • Distinct areas of strength: Cardiovascular (26 studies), dermatology, aesthetic and wound care (21) and orthopedic and spine (16) led the mix. Dermatology, aesthetics and wound care rank unusually high compared with other countries.
    • International use: 46 studies came from sponsors headquartered outside Italy, and 33 had sites in other countries.
    • One ethics opinion for a multi-site national study.

    Using data from Italy in a US submission

    The US Food and Drug Administration (FDA) can accept device data from outside the United States under the Code of Federal Regulations (CFR) at 21 CFR 812.28 if the study follows good clinical practice (GCP), including independent ethics review and informed consent, the sponsor supplies the required supporting information, and FDA can validate the data, if needed by inspection. The rule covers studies begun on or after 21 February 2019. FDA recognizes the International Organization for Standardization (ISO) device GCP standard, ISO 14155:2020; check the recognition status of the 2026 edition before you plan to it. Meeting 812.28 is not clearance or approval, and FDA may still ask for US data. Confirm your plan through a pre-submission under FDA’s Q-Submission (Q-Sub) program.

    How Latin America compares

    Italy uses one national ethics opinion but still requires Italian-language documents, and Rome is six hours ahead of US Eastern for most of the year. Across the 15 Latin American countries we track, the same query found 132 early-stage device studies in total. 38 of them were explicitly FIH or EFS, which is 12% of the 310 such studies worldwide, and 102 (77%) had US-headquartered sponsors. The region is used mainly for US companies’ first human data.

    • Time zone: Panama stays on UTC−5 (Coordinated Universal Time minus five) all year, the same as US Eastern Standard Time.
    • Regulation: each Latin American country has its own national pathway. We don’t quote a single clock; country planning ranges come with each proposal.
    • Ethics: bioaccess® publishes a 4–8 week median planning range for ethics review in its lead countries. This is based on our experience, not a formal study, and it is not a guarantee.
    • Cost: we don’t publish per-patient figures. Compare line-item budgets, including monitoring travel and translation.
    • Where we work: bioaccess® has focused on FIH studies since 2010. We lead execution in Panama, El Salvador, Chile and the Dominican Republic, with 50+ pre-qualified sites across 19 countries.

    When Italy is the better fit: for dermatology, aesthetic, wound-care or orthopedic devices with Italian investigators, or when EU data under the MDR is needed early. For a first implant that needs close US engineering support, compare a Latin American site.

    Frequently asked questions

    Who authorizes device investigations in Italy?

    The Ministry of Health, under Article 70 of the MDR. An ethics opinion is also required.

    How long does review take in Italy?

    The MDR allows 45 days from validation for invasive class IIa, IIb and III devices, plus 20 days for expert consultation, with clock stops for questions. We do not quote an Italian median because we found no official figure.

    Which documents need to be in Italian?

    The Careggi ethics committee’s instructions list the synopsis, labels, instructions for use and insurance documents in Italian.

    Can data from an Italian first-in-human study support an FDA submission?

    Yes, if the study meets 21 CFR 812.28 and FDA can validate the data. That makes the data reviewable. It is not clearance or approval.

    Next step

    Weighing Italy against Latin America for an FIH or EFS study? Book a call with Julio Martinez-Clark to review your device class, endpoints and FDA plan.

    Sources

  • First-in-Human Medical Device Trials in France

    France had the most early-stage device studies of any country outside the United States in our data, and more explicit first-in-human work than any other European country we profiled. This guide explains how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the registry shows, and when Latin America is the better first step for a United States (US) sponsor.

    What the registry shows

    Our query of ClinicalTrials.gov (CT.gov) found 141 early-stage, industry-sponsored device studies with at least one site in France, first posted between 1 January 2021 and 28 September 2026. That ranks France #2 worldwide on this measure. Of these, 47 used FIH, feasibility or pilot language in the title or summary, and 17 explicitly described a first-in-human or early feasibility study. 47 were run by sponsors headquartered outside France, 16 of them by US-headquartered companies, and 32 also listed sites in another country. Registrations went from 92 in 2021–2023 to 49 from January 2024 to September 2026.

    Method: bioaccess® analysis of the ClinicalTrials.gov (CT.gov) application programming interface (API) v2, run 28 September 2026: industry-sponsored interventional device studies first posted 1 January 2021 to 28 September 2026 (6,045). Early-stage means FIH, early feasibility, feasibility or pilot wording, or phase N/A with 50 or fewer planned participants (2,968 worldwide). Sponsor headquarters were inferred for 95% of studies. Counts are registrations, not approvals, and recent years are under-counted.

    How authorization works in France

    France applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745). Since 26 May 2021, the French Jardé law framework has not governed MDR device investigations. Two bodies review each study:

    • The National Agency for the Safety of Medicines and Health Products (Agence nationale de sécurité du médicament et des produits de santé, ANSM), which receives the dossier by email.
    • A Committee for the Protection of Persons (Comité de protection des personnes, CPP), the ethics committee. The CPP is assigned at random through the national SIRIPH2G platform.

    Process: the sponsor first gets an IDRCB number (the national identifier ANSM assigns to each study) and then submits to ANSM and the CPP on the same day. ANSM coordinates a 10-day validation, followed by a 45-day evaluation, extendable by 20 days if experts are consulted. According to ANSM’s procedures, silence from ANSM counts as authorization, while silence from the CPP counts as refusal. Sponsors based outside the EU need an EU legal representative (Art. 62(2) MDR).

    Where France is strong

    • Volume and FIH experience: 141 early studies and 17 explicitly FIH or EFS, the most of any European country we profiled.
    • A domestic innovation base: 92 studies were sponsored by French-headquartered companies.
    • A parallel review: ANSM and the CPP review at the same time from a same-day submission.
    • Clinical range: Cardiovascular (32 studies), ear, nose and throat and hearing (17) and orthopedic and spine (16) led the mix.

    Registrations did fall from 92 in 2021–2023 to 49 in 2024–2026. Part of that is registration lag, but the drop was larger than in most countries.

    Using data from France in a US submission

    The US Food and Drug Administration (FDA) can accept device data from outside the United States under the Code of Federal Regulations (CFR) at 21 CFR 812.28 if the study follows good clinical practice (GCP), including independent ethics review and informed consent, the sponsor supplies the required supporting information, and FDA can validate the data, if needed by inspection. The rule covers studies begun on or after 21 February 2019. FDA recognizes the International Organization for Standardization (ISO) device GCP standard, ISO 14155:2020; check the recognition status of the 2026 edition before you plan to it. Meeting 812.28 is not clearance or approval, and FDA may still ask for US data. Confirm your plan through a pre-submission under FDA’s Q-Submission (Q-Sub) program.

    How Latin America compares

    France runs the ethics and regulatory reviews in parallel, and Paris is six hours ahead of US Eastern for most of the year. Across the 15 Latin American countries we track, the same query found 132 early-stage device studies in total. 38 of them were explicitly FIH or EFS, which is 12% of the 310 such studies worldwide, and 102 (77%) had US-headquartered sponsors. The region is used mainly for US companies’ first human data.

    • Time zone: Panama stays on UTC−5 (Coordinated Universal Time minus five) all year, the same as US Eastern Standard Time.
    • Regulation: each Latin American country has its own national pathway. We don’t quote a single clock; country planning ranges come with each proposal.
    • Ethics: bioaccess® publishes a 4–8 week median planning range for ethics review in its lead countries. This is based on our experience, not a formal study, and it is not a guarantee.
    • Cost: we don’t publish per-patient figures. Compare line-item budgets, including monitoring travel and translation.
    • Where we work: bioaccess® has focused on FIH studies since 2010. We lead execution in Panama, El Salvador, Chile and the Dominican Republic, with 50+ pre-qualified sites across 19 countries.

    When France is the better fit: if your innovation partners or key opinion leaders are French, if you want EU data under the MDR early, or if your technology fits the strong French ear, nose and throat (ENT) and orthopedic base. US teams that want to attend the first cases in a US-aligned time zone should compare a Latin American option.

    Frequently asked questions

    How long does ANSM take to review a first-in-human device study?

    After a 10-day validation, ANSM has 45 days to evaluate, extendable by 20 days if experts are consulted. The CPP ethics review runs in parallel from a same-day submission.

    What happens if ANSM or the CPP does not respond in time?

    ANSM’s procedures say ANSM silence counts as authorization, while CPP silence counts as refusal.

    Does the Jardé law apply to device investigations in France?

    Not to investigations under the MDR since 26 May 2021, according to the CPP Sud-Méditerranée II guidance. An IDRCB number is still required.

    Can data from a French first-in-human study support an FDA submission?

    Yes, if the study meets 21 CFR 812.28 and FDA can validate the data. That makes the data reviewable. It is not clearance or approval.

    Next step

    Weighing France against Latin America for an FIH or EFS study? Book a call with Julio Martinez-Clark to review your device class, endpoints and FDA plan.

    Sources

  • First-in-Human Medical Device Trials in Poland

    Poland is one of the few European countries where early device study registrations grew between 2021–2023 and 2024–2026, and almost all of that work comes from foreign sponsors. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the registry shows, and how Latin America compares for a United States (US) sponsor.

    What the registry shows

    Our query of ClinicalTrials.gov (CT.gov) found 59 early-stage, industry-sponsored device studies with at least one site in Poland, first posted between 1 January 2021 and 28 September 2026. That ranks Poland #12 worldwide on this measure. Of these, 27 used FIH, feasibility or pilot language in the title or summary, and 10 explicitly described a first-in-human or early feasibility study. 49 were run by sponsors headquartered outside Poland, 18 of them by US-headquartered companies, and 27 also listed sites in another country. Registrations went from 28 in 2021–2023 to 31 from January 2024 to September 2026.

    Method: bioaccess® analysis of the ClinicalTrials.gov (CT.gov) application programming interface (API) v2, run 28 September 2026: industry-sponsored interventional device studies first posted 1 January 2021 to 28 September 2026 (6,045). Early-stage means FIH, early feasibility, feasibility or pilot wording, or phase N/A with 50 or fewer planned participants (2,968 worldwide). Sponsor headquarters were inferred for 95% of studies. Counts are registrations, not approvals, and recent years are under-counted.

    How authorization works in Poland

    Poland applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745) through the Act of 7 April 2022 on medical devices. Applications go to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, URPL).

    • Ethics first: the application must include a positive opinion from a bioethics committee, so the ethics step comes before the regulator’s review.
    • Timelines: URPL follows Article 70 of the MDR. Validation comes first. For invasive class IIa, IIb and III devices there are 45 days from validation, plus 20 days for expert consultation, with the clock stopped during questions.
    • Language: the application form may be in Polish or English. Patient information and consent forms must be in Polish.
    • Other items: proof of insurance and a fee set by the Minister of Health are required. Sponsors based outside the EU need an EU legal representative (Art. 62(2) MDR).

    Where Poland is strong

    • Built for foreign sponsors: 49 of 59 early studies (83%) came from sponsors headquartered outside Poland, the highest share among the countries we profiled.
    • Growth: registrations went from 28 to 31 across the two periods, even though the second period is shorter.
    • Cardiovascular focus: Cardiovascular (30 studies), oncology (6) and orthopedic and spine (5) led the mix. Cardiovascular made up about half of all early studies.
    • FIH work: 10 studies were explicitly FIH or EFS.

    Using data from Poland in a US submission

    The US Food and Drug Administration (FDA) can accept device data from outside the United States under the Code of Federal Regulations (CFR) at 21 CFR 812.28 if the study follows good clinical practice (GCP), including independent ethics review and informed consent, the sponsor supplies the required supporting information, and FDA can validate the data, if needed by inspection. The rule covers studies begun on or after 21 February 2019. FDA recognizes the International Organization for Standardization (ISO) device GCP standard, ISO 14155:2020; check the recognition status of the 2026 edition before you plan to it. Meeting 812.28 is not clearance or approval, and FDA may still ask for US data. Confirm your plan through a pre-submission under FDA’s Q-Submission (Q-Sub) program.

    How Latin America compares

    Poland requires the bioethics opinion before it reviews the application, and Warsaw is six hours ahead of US Eastern for most of the year. Across the 15 Latin American countries we track, the same query found 132 early-stage device studies in total. 38 of them were explicitly FIH or EFS, which is 12% of the 310 such studies worldwide, and 102 (77%) had US-headquartered sponsors. The region is used mainly for US companies’ first human data.

    • Time zone: Panama stays on UTC−5 (Coordinated Universal Time minus five) all year, the same as US Eastern Standard Time.
    • Regulation: each Latin American country has its own national pathway. We don’t quote a single clock; country planning ranges come with each proposal.
    • Ethics: bioaccess® publishes a 4–8 week median planning range for ethics review in its lead countries. This is based on our experience, not a formal study, and it is not a guarantee.
    • Cost: we don’t publish per-patient figures. Compare line-item budgets, including monitoring travel and translation.
    • Where we work: bioaccess® has focused on FIH studies since 2010. We lead execution in Panama, El Salvador, Chile and the Dominican Republic, with 50+ pre-qualified sites across 19 countries.

    When Poland is the better fit: for cardiovascular programs that need EU data under the MDR and sites used to foreign sponsors. For a very first implant where the US engineering team wants to attend, compare a Latin American option on time zone and travel.

    Frequently asked questions

    How long does URPL take to authorize a device investigation?

    URPL follows the MDR’s Article 70 timelines: validation, then 45 days for invasive class IIa, IIb and III devices, plus 20 days for experts, with clock stops for questions. The bioethics opinion must be in hand first.

    Is a bioethics committee opinion needed before applying to URPL?

    Yes. URPL requires a positive bioethics committee opinion to accompany the application.

    Which documents must be in Polish?

    Patient information and consent forms must be in Polish. The application form itself may be in Polish or English.

    Can data from a Polish first-in-human study support an FDA submission?

    Yes, if the study meets 21 CFR 812.28 and FDA can validate the data. That makes the data reviewable. It is not clearance or approval.

    Next step

    Weighing Poland against Latin America for an FIH or EFS study? Book a call with Julio Martinez-Clark to review your device class, endpoints and FDA plan.

    Sources

  • First-in-Human Medical Device Trials in Belgium

    Belgium is small, but it runs an unusually high share of true first-in-human work. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the public registry shows, and where Latin America fits for United States (US) sponsors.

    What the registry shows

    Our query of ClinicalTrials.gov (CT.gov) found 77 early-stage, industry-sponsored device studies with at least one site in Belgium, first posted between 1 January 2021 and 28 September 2026. That ranks Belgium #11 worldwide on this measure. Of these, 37 used FIH, feasibility or pilot language in the title or summary, and 12 explicitly described a first-in-human or early feasibility study. 52 were run by sponsors headquartered outside Belgium, 14 of them by US-headquartered companies, and 42 also listed sites in another country. Registrations went from 44 in 2021–2023 to 33 from January 2024 to September 2026.

    Method: bioaccess® analysis of the ClinicalTrials.gov (CT.gov) application programming interface (API) v2, run 28 September 2026: industry-sponsored interventional device studies first posted 1 January 2021 to 28 September 2026 (6,045). Early-stage means FIH, early feasibility, feasibility or pilot wording, or phase N/A with 50 or fewer planned participants (2,968 worldwide). Sponsor headquarters were inferred for 95% of studies. Counts are registrations, not approvals, and recent years are under-counted.

    How authorization works in Belgium

    Belgium applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745) through the Law of 22 December 2020 and the Royal Decree of 18 May 2021. The Federal Agency for Medicines and Health Products (FAMHP) runs a single-submission model:

    • One dossier, one decision: the sponsor submits once through the Common European Submission Portal (CESP). FAMHP and an ethics committee assess it together and issue one consolidated decision.
    • Timeline: FAMHP validates within 10 days, and the acknowledgement of receipt marks day T0. Questions arrive by T28. There is one round of questions, with a clock stop of up to 20 days. The decision comes by T45, or T65 if experts are consulted.
    • Every class is assessed: Belgium does not use the shorter notification route the MDR allows for lower-risk devices, so each investigation gets a full assessment.
    • Sponsors based outside the EU need a legal representative in the EU (Art. 62(2) MDR).

    Where Belgium is strong

    • FIH focus: 12 of 77 early studies (16%) were explicitly FIH or EFS, one of the highest shares in Europe in our data.
    • Multinational use: 42 studies also had sites in other countries, and 52 came from sponsors headquartered outside Belgium.
    • A predictable process: a single portal, a joint ethics and regulatory review, and published day targets (T0, T28, T45).
    • Therapeutic depth: Cardiovascular (23 studies), ear, nose and throat and hearing (11) and orthopedic and spine (9) led the mix.

    Using data from Belgium in a US submission

    The US Food and Drug Administration (FDA) can accept device data from outside the United States under the Code of Federal Regulations (CFR) at 21 CFR 812.28 if the study follows good clinical practice (GCP), including independent ethics review and informed consent, the sponsor supplies the required supporting information, and FDA can validate the data, if needed by inspection. The rule covers studies begun on or after 21 February 2019. FDA recognizes the International Organization for Standardization (ISO) device GCP standard, ISO 14155:2020; check the recognition status of the 2026 edition before you plan to it. Meeting 812.28 is not clearance or approval, and FDA may still ask for US data. Confirm your plan through a pre-submission under FDA’s Q-Submission (Q-Sub) program.

    How Latin America compares

    Belgium’s joint review is one of the most streamlined in the EU, and Brussels is six hours ahead of US Eastern for most of the year. Across the 15 Latin American countries we track, the same query found 132 early-stage device studies in total. 38 of them were explicitly FIH or EFS, which is 12% of the 310 such studies worldwide, and 102 (77%) had US-headquartered sponsors. The region is used mainly for US companies’ first human data.

    • Time zone: Panama stays on UTC−5 (Coordinated Universal Time minus five) all year, the same as US Eastern Standard Time.
    • Regulation: each Latin American country has its own national pathway. We don’t quote a single clock; country planning ranges come with each proposal.
    • Ethics: bioaccess® publishes a 4–8 week median planning range for ethics review in its lead countries. This is based on our experience, not a formal study, and it is not a guarantee.
    • Cost: we don’t publish per-patient figures. Compare line-item budgets, including monitoring travel and translation.
    • Where we work: bioaccess® has focused on FIH studies since 2010. We lead execution in Panama, El Salvador, Chile and the Dominican Republic, with 50+ pre-qualified sites across 19 countries.

    When Belgium is the better fit: if you want a single consolidated EU decision with published day targets, and European data is part of your plan. For a first implant where the US team wants to be present in person, a Latin American site in a nearby time zone is worth comparing.

    Frequently asked questions

    How long does FAMHP take to decide on a device investigation?

    FAMHP validates within 10 days (T0), sends questions by T28 with up to a 20-day clock stop, and decides by T45, or T65 if experts are consulted.

    Do ethics and FAMHP review separately in Belgium?

    No. One dossier goes through CESP, and FAMHP and an ethics committee assess it together to issue one consolidated decision.

    Are low-risk devices exempt from full assessment in Belgium?

    No. FAMHP’s guideline says Belgium fully assesses investigations of every device class.

    Can data from a Belgian first-in-human study support an FDA submission?

    Yes, if the study meets 21 CFR 812.28 and FDA can validate the data. That makes the data reviewable. It is not clearance or approval.

    Next step

    Weighing Belgium against Latin America for an FIH or EFS study? Book a call with Julio Martinez-Clark to review your device class, endpoints and FDA plan.

    Sources