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  • First-in-Human Medical Device Trials in Spain

    Spain has one of Europe’s largest early device study counts and a strong home-grown device sector. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the public registry shows, and how Spain 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 Spain, first posted between 1 January 2021 and 28 September 2026. That ranks Spain #6 worldwide on this measure. Of these, 48 used FIH, feasibility or pilot language in the title or summary, and 13 explicitly described a first-in-human or early feasibility study. 55 were run by sponsors headquartered outside Spain, 21 of them by US-headquartered companies, and 37 also listed sites in another country. Registrations went from 62 in 2021–2023 to 54 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 Spain

    Spain applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745) with Royal Decree 192/2023. According to the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS), each site needs three things before it can start:

    1. AEMPS authorization. The application follows Annex XV of the MDR and is sent with proof that the fee was paid.
    2. A single, binding favourable opinion from an accredited research ethics committee for medicines (Comité de Ética de la Investigación con medicamentos, CEIm).
    3. Agreement from the site’s management (conformidad de la dirección del centro).

    Timelines: AEMPS’s instructions (updated 29 December 2025) give 45 calendar days for most devices. For now, class I and non-invasive class IIa/IIb devices keep a one-month period under the older Royal Decree 1591/2009. AEMPS says the 45-day period will apply to every class once a new royal decree is published. The MDR allows 20 more days for expert consultation. The ethics review can run in parallel, but AEMPS needs the favourable CEIm opinion to authorize.

    Language: AEMPS allows the protocol and investigator’s brochure in English if the CEIm agrees. Patient information, consent forms and labels must be in Spanish. Sponsors based outside the EU need an EU legal representative (Art. 62(2) MDR).

    Where Spain is strong

    • A deep domestic sector: 60 of 116 early studies were sponsored by Spanish-headquartered companies, and 13 were explicitly FIH or EFS.
    • International use too: 55 studies came from sponsors headquartered elsewhere.
    • Clinical range: Cardiovascular (27 studies), neurology (20) and oncology (13) led the mix, with neurology unusually strong.
    • Spanish-language materials: consent forms and patient materials written for Spain are a useful starting point for Spanish-speaking Latin American sites, though each country’s ethics committee still reviews its own version.

    Using data from Spain 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

    Spain’s ethics and regulatory reviews can overlap, but the 45-day AEMPS clock still applies to most FIH devices, and Madrid 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 Spain is the better fit: if you want EU data under the MDR, your investigators are Spanish, or neurology is your area. A Spain-plus-Latin America plan also lets you reuse Spanish-language documents across both regions.

    Frequently asked questions

    How long does AEMPS take to authorize a device investigation?

    AEMPS’s current instructions give 45 calendar days for most devices, and one month for class I and non-invasive class IIa/IIb devices until a new royal decree is published. The MDR adds 20 days if experts are consulted.

    Can the CEIm ethics review run in parallel with AEMPS?

    Yes, but AEMPS needs the CEIm’s favourable opinion in order to authorize. The CEIm issues a single, binding opinion.

    Which documents must be in Spanish?

    Patient information, consent forms and labels must be in Spanish. The protocol and investigator’s brochure may be in English if the CEIm agrees.

    Can data from a Spanish 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 Spain 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 the UK

    The United Kingdom (UK) draws more United States (US) device companies than any other European country in our data. This guide explains how a first-in-human (FIH) or early feasibility study (EFS) is notified in Great Britain, what the registry shows, and where Latin America fits.

    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 the UK, first posted between 1 January 2021 and 28 September 2026. That ranks the UK #8 worldwide on this measure. Of these, 48 used FIH, feasibility or pilot language in the title or summary, and 10 explicitly described a first-in-human or early feasibility study. 68 were run by sponsors headquartered outside the UK, 36 of them by US-headquartered companies, and 31 also listed sites in another country. Registrations went from 56 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 notification works in Great Britain

    Great Britain (England, Scotland and Wales) runs device investigations under the UK Medical Devices Regulations 2002 (UK MDR 2002). Northern Ireland follows European Union (EU) rules, so this section covers Great Britain only.

    • 60-day notice: the manufacturer, or its UK Responsible Person, must give the Medicines and Healthcare products Regulatory Agency (MHRA) 60 days’ notice before investigational devices are supplied. The application goes through the Integrated Research Application System (IRAS). If MHRA has not objected within 60 days of formally accepting the notice, the study may go ahead. MHRA’s guidance says the clock does not stop for information requests in Great Britain, and a fee applies.
    • Ethics: a favourable opinion from one Research Ethics Committee (REC) within the UK Health Departments’ Research Ethics Service is needed, however many sites take part. It can run in parallel with MHRA review. MHRA does not accept approvals from independent ethics committees.
    • Health service approval: for research in the National Health Service (NHS) in England and Wales, Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approval combines governance checks with the REC opinion.
    • Start: a study of a device without UK Conformity Assessed (UKCA) or CE (Conformité Européenne) marking may start only when the REC has given a favourable opinion and MHRA has raised no objection.

    Where the UK is strong

    • US sponsor familiarity: 36 of 108 early studies (33%) were sponsored by US-headquartered companies, the highest share among the ten countries we profiled, just ahead of the Netherlands.
    • A fixed clock: a 60-day decision window that does not stop for questions is easy to plan around.
    • English throughout.
    • Therapeutic depth: Cardiovascular (20 studies), ophthalmology (17) and kidney and urology (13) led the early-study mix.

    Using data from the UK 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 UK’s 60-day MHRA window is fixed, and London is five 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 UK is the better fit: if your clinical advisers are NHS-based, you want English-language sites with a fixed regulatory window, or your UK market entry is near-term. If you need faster enrollment in a US-aligned time zone for a first implant, compare a Latin American site side by side.

    Frequently asked questions

    How long does MHRA take to review a device investigation?

    MHRA has 60 days from formally accepting the notice to object. If it does not object and a Research Ethics Committee has given a favourable opinion, the study can start. MHRA says the clock does not stop for information requests in Great Britain.

    Do I need a UK Responsible Person to notify MHRA?

    The notice comes from the manufacturer or its UK Responsible Person. Non-UK manufacturers usually act through a UK Responsible Person.

    Can ethics review run at the same time as MHRA review?

    Yes. MHRA guidance says the REC opinion may be obtained in parallel. One REC opinion covers all sites.

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

    Yes, if the study meets 21 CFR 812.28 (good clinical practice, independent ethics review, informed consent and supporting information) and FDA can validate the data. Acceptance is not clearance or approval.

    Next step

    Weighing the UK 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 Germany

    Germany is one of Europe’s busiest settings for early device studies, much of it for foreign sponsors. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the public registry shows, and when a Latin American site is the better first step for a United States (US) company.

    What the registry shows

    Our query of ClinicalTrials.gov (CT.gov) found 107 early-stage, industry-sponsored device studies with at least one site in Germany, first posted between 1 January 2021 and 28 September 2026. That ranks Germany #9 worldwide on this measure. Of these, 46 used FIH, feasibility or pilot language in the title or summary, and 9 explicitly described a first-in-human or early feasibility study. 72 were run by sponsors headquartered outside Germany, 19 of them by US-headquartered companies, and 40 also listed sites in another country. Registrations went from 59 in 2021–2023 to 48 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 Germany

    Germany applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745) through the Medical Devices Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG). The steps run in sequence. The sponsor first submits to the competent ethics committee. Only after a favourable opinion does the same application go to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), through the German Medical Devices Information and Database System (DMIDS).

    • Class I and non-invasive class IIa devices (Art. 70(7)(a) MDR with §31(1) MPDG) use a shorter procedure. The study may start once the ethics committee has given a favourable opinion and BfArM has raised no objection after validation.
    • Invasive class IIa, class IIb and class III devices, which covers most FIH implants, need full authorization under Art. 70(7)(b) MDR and §31(2) MPDG. The MDR allows 45 days from validation, plus 20 days if experts are consulted, and the clock stops while the sponsor answers questions.
    • Sponsors based outside the EU must name a legal representative in the EU (Art. 62(2) MDR).

    Where Germany is strong

    • International demand: 72 of 107 early studies (67%) were run by sponsors headquartered outside Germany, and 40 also had sites in other countries. A sign that sites are used to foreign sponsors.
    • Clear rules: statutory MDR clocks and detailed BfArM guidance on DMIDS.
    • A route to the EU market: a study authorized under the MDR can feed the clinical evaluation for CE (Conformité Européenne) marking.
    • Therapeutic depth: Cardiovascular (26 studies), ear, nose and throat and hearing (15) and oncology (11) led the early-study mix.

    Using data from Germany 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

    Germany’s sequential model means ethics and regulator reviews add up rather than overlap, and Central European Time 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 Germany is the better fit: if the EU is your first market and you need MDR data early, or your key opinion leaders are German, starting there can save a second study. You can also do both: FIH in Latin America, then a European study once the design settles.

    Frequently asked questions

    How long does BfArM take to authorize a first-in-human device study?

    For invasive class IIa, IIb and III devices, the MDR allows 45 days from validation, extendable by 20 days for expert consultation, with the clock stopped during questions. In Germany the ethics committee reviews first, so total time also depends on the ethics phase.

    Does the ethics committee review run in parallel with BfArM in Germany?

    No. Germany uses a sequential procedure: the application goes to the ethics committee first and is sent to BfArM through DMIDS only after a favourable opinion.

    Does a US company need an EU representative to run a device study in Germany?

    Yes. Under Article 62(2) of the MDR, a sponsor not established in the EU must have a legal representative in the EU.

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

    It can, if the study meets 21 CFR 812.28: good clinical practice, independent ethics review, informed consent and the required supporting information, with data FDA can validate. That makes the data reviewable. It is not clearance or approval.

    Next step

    Weighing Germany 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

  • Vantage Clinical in Kazakhstan, and Where Latin America Fits

    General information, not legal or regulatory advice. bioaccess® does not speak for Vantage. Statements about Vantage are attributed to its public website (vantage-ct.com) and its newsletter, The Vantage Brief, as of 28 September 2026. Confirm any detail that matters to your program with Vantage directly.

    If you searched Vantage Clinical, Vantage Kazakhstan, or vantage-ct, you are probably weighing Kazakhstan for an early-phase clinical trial. This page does three things. It separates the Kazakhstan platform from a U.S. site network with a similar name. It summarizes what Vantage publicly says it offers. And it explains where Latin America, and bioaccess®, The First-in-Human CRO (contract research organization), fit when your program includes a medical device first-in-human (FIH) study.

    First, which “Vantage”?

    Two unrelated organizations show up for this search:

    • Vantage Clinical (vantage-ct.com). Describes itself as sovereign-backed clinical trial infrastructure in Kazakhstan, built by biotech operators and investors. It lists locations in New York, Dubai, and Astana, and its site footer uses the name “Vantage Clinical Trials.” The Vantage Brief lists Charlie Regis, Almas Kenessary, and Zach Lomis as co-founders and partners, and Didar Bitmanov as chief operating officer (COO).
    • Vantage Clinical Trials (vantagetrials.com). An independent clinical research site network in the Tampa Bay area of Florida, founded in 2018, with sites in Tampa, St. Petersburg, and The Villages.

    This page is about the first one.

    What Vantage says it offers in Kazakhstan

    Vantage calls itself “the Kazakhstan layer”: the in-country platform, while sponsors keep flexibility on which CRO they use. Its website lists four parts:

    • Government integration. Direct ministerial relationships and sovereign backing.
    • Site and principal investigator (PI) network. Government-owned hospitals, Joint Commission International (JCI)-accredited facilities, and in-country site contracting, qualification, and activation.
    • Accelerated recruitment. A centralized digital health database that Vantage says covers 20 million citizens.
    • Regulatory navigation. Local approvals coordinated with Kazakhstan’s National Center for Drugs and Medical Devices Evaluation, with protocols built around International Council for Harmonisation (ICH) E6(R2) Good Clinical Practice (GCP).

    Vantage describes itself as CRO-agnostic. Sponsors can bring their existing CRO, or Vantage coordinates with global CROs. Its newsletter names Tigermed as its global CRO partner. Its feasibility form covers first-in-human and proof-of-concept (POC) studies through Phase 3. Its June 2026 newsletter describes a first-in-human feasibility study of a bioresorbable peripheral vascular scaffold at a national hospital in Astana.

    Vantage also publishes performance figures for Kazakhstan, such as 2–3x faster enrollment, 20–30% of Western cost, and 250+ completed and ongoing trials in the country. Those are Vantage’s figures. bioaccess® has not independently checked them, and we do not repeat them as our own. If a number matters to your budget, ask Vantage what it is based on.

    Where Latin America fits

    Kazakhstan and Latin America are not an either/or choice. They can answer different questions in an early-stage plan. bioaccess® has focused on first-in-human and early feasibility studies (EFS) since 2010. Most of our sponsors are U.S. medical device startups. We anchor on U.S. regulatory strategy and run studies across a defined list of 19 Latin American and Caribbean countries.

    Three situations where Latin America is worth a look alongside a Kazakhstan plan:

    1. Device-first programs. If your first human milestone is a device FIH or EFS, Latin America offers pre-qualified sites with small-cohort device experience, in time zones close to the U.S. Later-phase or larger cohorts can go wherever your regulatory strategy points, Kazakhstan included.
    2. A second geography. Early-phase plans often stall for reasons unrelated to the science: a site’s calendar, an import permit, a regulator’s queue. A second country in a different region lowers single-country risk.
    3. Hands-on oversight from the U.S. Some sponsor teams want to be in the room for the first cases. Short flights and overlapping working hours make that practical in Latin America.

    Neither region is automatically faster or cheaper for every protocol. Match the geography to the device, the U.S. Food and Drug Administration (FDA) pathway, and what your investors need to see.

    At a glance

    Kazakhstan via Vantage Latin America via bioaccess®
    What it is In-country platform: government integration, sites, recruitment, regulatory navigation (per vantage-ct.com) First-in-human CRO: U.S. regulatory anchoring plus Latin American execution (per bioaccessla.com)
    CRO model CRO-agnostic; names Tigermed as global CRO partner bioaccess® is the CRO
    Stages listed publicly FIH and POC through Phase 3 FIH and EFS
    Geography Kazakhstan; offices listed in New York, Dubai, Astana 19 Latin American and Caribbean countries; headquartered in Miami
    Sites Government-owned hospitals and JCI-accredited facilities 50+ pre-qualified sites
    FDA rule for foreign data Vantage cites 21 CFR 312.120 (U.S. Code of Federal Regulations; drugs and biologics) 21 CFR 812.28 (devices); eligibility is not clearance
    First contact info@vantage-ct.com Schedule time with Julio Martinez-Clark

    FDA and foreign data, briefly

    FDA does not keep a country scorecard. For drugs and biologics, FDA considers foreign clinical data under 21 CFR 312.120. For devices, 21 CFR 812.28 lets FDA accept data from studies outside the U.S. to support an investigational device exemption (IDE) or a marketing submission, when the study followed GCP (for devices, usually ISO 14155, the International Organization for Standardization standard for device trials), had independent ethics review and informed consent, and FDA can validate the data, including by inspection if needed. Eligibility is not clearance or approval. Plan the bridge with FDA early, usually through a Pre-Submission meeting. More detail: Does the FDA accept clinical data from Latin America? and Can first-in-human data from outside the U.S. support an FDA IDE submission?

    Related pages

    Frequently asked questions

    Is Vantage Clinical the same company as Vantage Clinical Trials in Florida?

    No. Vantage Clinical (vantage-ct.com) is a clinical trial platform focused on Kazakhstan, with offices listed in New York, Dubai, and Astana. Vantage Clinical Trials (vantagetrials.com) is an independent research site network in the Tampa Bay area of Florida, founded in 2018. They are separate organizations.

    Is bioaccess® part of Vantage?

    No. bioaccess® and Vantage are independent companies. bioaccess® is The First-in-Human CRO, headquartered in Miami and focused on the U.S. and Latin America. If your plan includes both Kazakhstan and Latin America, tell us and we will coordinate with your Kazakhstan partner.

    Does Vantage run medical device trials?

    Vantage’s feasibility form lists first-in-human and proof-of-concept studies through Phase 3, and its June 2026 newsletter describes a first-in-human feasibility study of a bioresorbable peripheral vascular scaffold at a national hospital in Astana. For specifics on devices in Kazakhstan, ask Vantage directly.

    Will the FDA accept data from Kazakhstan or Latin America?

    FDA decides case by case, not by country. It considers foreign drug and biologic data under 21 CFR 312.120 and foreign device data under 21 CFR 812.28, looking at GCP compliance, ethics review, informed consent, and whether it can validate the data. Eligibility is not clearance or approval, so align the plan with FDA early, usually through a Pre-Submission meeting.

    Can one program use both Kazakhstan and Latin America?

    Yes. Sequencing the two regions is usually simpler than running both under one protocol at the same time, because each has its own regulator, ethics committees, language, and import logistics. One sequence to consider: a device first-in-human or early feasibility study in Latin America, then larger or later-phase cohorts wherever your regulatory strategy points.

    How do I start a conversation?

    For Kazakhstan feasibility, contact Vantage at info@vantage-ct.com. For a device first-in-human or early feasibility study in Latin America, schedule time with Julio Martinez-Clark, CEO of bioaccess®, at bioaccessla.com/schedule-time-with-julio-martinez-clark.

    Next step

    Planning a device first-in-human study and weighing Kazakhstan, Latin America, or both? Schedule time with Julio Martinez-Clark, CEO of bioaccess®.

    Schedule time with Julio Martinez-Clark

  • Considering Clinical Accelerator? How Eastern Europe, the Caucasus and Central Asia Compare with Latin America for Device First-in-Human Studies

    bioaccess® is not affiliated with Clinical Accelerator. Facts about Clinical Accelerator come from its public website and ClinicalTrials.gov, checked 28 September 2026. General information, not legal or regulatory advice.

    If you searched for Clinical Accelerator, you are probably a MedTech founder planning a first-in-human (FIH) study or an early feasibility study (EFS) and deciding where to run it. Clinical Accelerator is an established medical device contract research organization (CRO) in Eastern Europe, the Caucasus and Central Asia. bioaccess® runs device FIH and EFS programs in Latin America. This page compares the two regions honestly. Both can produce credible early data.

    What Clinical Accelerator says about itself

    From its own public pages:

    • It describes itself as “The Sponsor-Aligned CRO for First-in-Human and Early Feasibility Trials” for novel medical devices.
    • Its homepage coverage map lists Armenia, Bulgaria, Czechia, Georgia, Lithuania, Poland, Serbia, Ukraine and Uzbekistan. The team page names country leads for Georgia and Uzbekistan, plus clinical operations for Lithuania and the EU.
    • The homepage cites 200+ FIH and EFS trials run, 60+ dedicated clinical sites, a 150MM+ patient population, and about 60 days on average from kickoff to first patient in (FPI). It adds that timelines vary by indication and country.
    • Its experience page centers on cardiovascular devices (heart failure, transcatheter valves, interatrial shunts, renal denervation, electrophysiology, neurovascular), plus oncology and other areas.
    • ClinicalTrials.gov names Clinical Accelerator as a collaborator on nine records. Their sites include Georgia, Uzbekistan and Ukraine.

    These are Clinical Accelerator’s own statements. We have not audited them and we are not disputing them. Kazakhstan and Moldova are not on its map. Our country guides for them are linked below.

    The same U.S. data-acceptance rule applies to both regions

    Under 21 CFR 812.28, the U.S. Food and Drug Administration (FDA) accepts device data from outside the United States to support an investigational device exemption (IDE), 510(k), De Novo request or premarket approval (PMA) application. The study must be well designed and well conducted under good clinical practice (GCP), including independent ethics committee (IEC) review and informed consent, and FDA must be able to validate the data, by onsite inspection if it decides one is needed. If a PMA relies only on foreign data, 21 CFR 814.15 adds that the data must apply to the U.S. population and U.S. medical practice.

    The rule does not favor or penalize any country. What counts is protocol quality, conduct under ISO 14155 (the international GCP standard for device investigations), monitoring and data integrity. More: FDA acceptance.

    Where Eastern Europe, the Caucasus and Central Asia are strong

    • Recent device-specific rules. Georgia adopted a technical regulation for device clinical research in October 2023 (Resolution No. 386), and a published summary says it references ISO 14155:2020 and International Council for Harmonisation (ICH) GCP. A new Uzbek regulation on device clinical trials took effect on 26 February 2026. Serbia’s Medicines and Medical Devices Agency (ALIMS) takes the agency application and the national ethics application at the same time.
    • Short published approval clocks. Moldova’s medicines and device agency says it issues its opinion within 30 working days of a complete application. CROs working in Georgia publish approval timelines of under two months.
    • An early-device track record. ClinicalTrials.gov lists 14 Georgia records whose primary purpose is marked “device feasibility.” Among the countries on this page, only Brazil has more (15).
    • Specialist cardiovascular depth, a real advantage for structural heart and heart failure devices.

    Where Latin America is strong

    • Your time zone. Panama City and Bogotá are on UTC−5 (Coordinated Universal Time minus five hours) and Santiago and São Paulo on UTC−3, 0–2 hours from U.S. Eastern time. Belgrade to Tashkent runs about 6–10 hours ahead.
    • Large patient populations. World Bank 2024 figures: Brazil about 212 million, Mexico about 131 million, Argentina about 46 million. On ClinicalTrials.gov, Brazil has 1,170 interventional device records, Mexico 244 and Chile 199.
    • Published clocks. Our Panama hub publishes ethics approval in 3–5 weeks, with MINSA (Ministry of Health) clearance available at the same time, and a 6–8 week average to first patient with bioaccess® coordination. Our Brazil hub publishes 6–10 weeks for ANVISA (Agência Nacional de Vigilância Sanitária) plus ethics review. Argentina’s ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) regulates device clinical investigations under Disposition 969/1997.
    • One team from FIH to the United States. bioaccess® is headquartered in Miami. Its sister organization, Amavita Research Services, runs a Miami clinical research site for device and early feasibility studies.

    Latin America has trade-offs too: Spanish or Portuguese documents, investigational import permits, and uneven regulator predictability. Colombia’s INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) clinical-trial timelines have recently been harder to forecast. Small countries such as Panama (about 4.5 million people) carry the same narrow-pool risk as Georgia or Armenia.

    Side-by-side comparison

    Factor Eastern Europe, Caucasus and Central Asia Latin America (bioaccess®)
    Example pathways Georgia: agency registration certificate plus a local ethics committee opinion at each site. Kazakhstan: national expert review, bioethics commission, then a Ministry of Healthcare permit. Serbia: ALIMS and national ethics filed together Panama: MINSA plus ethics committees registered with the national bioethics committee (CNBI). Brazil: ANVISA resolution RDC 837/2023 plus institutional research ethics committees (CEPs). Argentina: ANMAT plus ethics
    Published timing Clinical Accelerator: about 60 days kickoff to FPI (its average). Moldova: agency opinion within 30 working days of a complete file Panama: 3–5 week ethics and a 6–8 week average to first patient (bioaccess® hub). Brazil: 6–10 weeks, ANVISA plus ethics
    GCP standard ISO 14155 cited in Georgian and Kazakh rules bioaccess® runs device studies under ISO 14155
    FDA use of data 21 CFR 812.28 (same rule) 21 CFR 812.28 (same rule)
    Interventional device records on ClinicalTrials.gov (28 Sep 2026) Serbia 97, Georgia 90, Ukraine 54, Armenia 36, Kazakhstan 26, Uzbekistan 23, Moldova 3 Brazil 1,170, Mexico 244, Chile 199, Colombia 118, Argentina 111, Panama 39
    Time difference from U.S. Eastern About 6–10 hours ahead About 0–2 hours
    Languages for documents Georgian, Armenian, Kazakh or Russian, Uzbek, Romanian, Ukrainian, Serbian Spanish, Portuguese

    Registry counts cover all interventional device studies, not just FIH. They show footprint, not quality.

    Questions to ask any FIH CRO, in either region

    1. Which regulator and ethics body will review my device class, and who is the legal applicant or local representative?
    2. Can I have a written, study-specific calendar, including what pauses the clock?
    3. How many patients meeting my inclusion criteria did the named sites treat last year? Strict criteria shrink eligible pools fast, especially in small countries or when one hospital dominates referrals.
    4. Which implanting physicians will do the cases, and what similar devices have they used?
    5. How will monitoring, data and safety reporting be packaged for 812.28? Who handles import, insurance and translations?

    See also: how to compare CRO proposals for FIH trials.

    Where bioaccess® fits

    If Clinical Accelerator’s region and cardiovascular focus suit your device, it is a serious option. If you want a start in your own time zone, large Latin American populations, and one team that can carry the program into a U.S. early feasibility study, talk to us. See First-in-Human CRO and early feasibility studies.

    Country guides: Georgia · Uzbekistan · Kazakhstan · Armenia · Moldova · Ukraine · Serbia

    Frequently asked questions

    Is bioaccess® affiliated with Clinical Accelerator?

    No. They are independent companies working in different regions. This page relies only on Clinical Accelerator’s public website and ClinicalTrials.gov.

    Will the FDA accept first-in-human data from Georgia or Uzbekistan?

    The same rule, 21 CFR 812.28, applies to data from any country outside the United States. The study must follow GCP, including ethics review and informed consent, and FDA must be able to validate the data. Acceptance is decided case by case, and the rule does not favor one region over another.

    Which region starts faster?

    Both publish short clocks: Clinical Accelerator cites about 60 days on average from kickoff to first patient, and our Panama hub a 6–8 week average to first patient with bioaccess® coordination. Compare written, study-specific calendars, not averages.

    Which countries does Clinical Accelerator cover?

    Its homepage map lists Armenia, Bulgaria, Czechia, Georgia, Lithuania, Poland, Serbia, Ukraine and Uzbekistan. Please confirm current coverage with Clinical Accelerator directly.

    Can I use both regions in one program?

    Yes. Each country needs its own ethics and regulatory approvals. Collect the data to one protocol and one GCP standard.

    Next step

    Want an honest read on which region fits your device? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • Medical Device Clinical Trials in Serbia: Agency and Ethics Approval, Real Strengths, and How Latin America Compares

    General information, not legal or regulatory advice. Sources were checked on 28 September 2026. bioaccess® does not run studies in Serbia and is not affiliated with any company named here.

    Serbia is a non-EU country in the Western Balkans with a long clinical-trial history, and it appears on the coverage maps of some device contract research organizations (CROs), including Clinical Accelerator’s. If you are a MedTech founder weighing Serbia for a first-in-human (FIH) or early feasibility study (EFS), this page covers the pathway as the Serbian regulator publishes it, what Serbia offers, and how a Latin American start compares.

    The pathway, from the regulator’s website

    Serbia’s Medicines and Medical Devices Agency (ALIMS) says clinical trials of medical devices require two things:

    1. an authorization, or for lower-risk studies a certificate of registration, issued by ALIMS, and
    2. a positive opinion from the Ethics Committee of Serbia (ECS),

    both under the Law on Medical Devices (Official Gazette of the Republic of Serbia No. 105/2017) and its implementing regulations. ALIMS states that the agency application and the ECS application are submitted through the Agency at the same time.

    Authorization is required before starting investigations of:

    • Class IIa devices intended for long-term use or that are invasive,
    • Class IIb devices,
    • Class III devices, and
    • active implantable medical devices (AIMD).

    Registration, which is a notification route, applies to post-market non-interventional studies, Class I devices, Class IIa devices that are not long-term or invasive, and performance studies of in vitro diagnostics. Academic (non-commercial) device trials follow whichever route applies.

    Most FIH devices are Class IIb, Class III or implantable, so expect the authorization route.

    What is published about timelines

    The ALIMS device clinical-trials page does not state a review clock. Some legal guides cite statutory review deadlines, but check the current law and ask for a written, study-specific calendar.

    Standards and U.S. data acceptance

    The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study is well designed and well conducted under good clinical practice (GCP), with independent ethics review and informed consent, and FDA can validate the data. The data can support an investigational device exemption (IDE), 510(k), De Novo or premarket approval (PMA) submission. Run the study to ISO 14155, the international GCP standard for device investigations.

    Patients, sites and device experience

    • Population: about 6.6 million (World Bank, 2024).
    • ClinicalTrials.gov (28 September 2026): 1,855 records of all types list a site in Serbia. Of these, 97 are interventional device records, and 3 have “device feasibility” as their primary purpose.
    • Clinical Accelerator includes Serbia on its coverage map. See our regional comparison.

    Recruitment reality: Serbia’s broad trial experience helps, but in a country of about 6.6 million, a narrow indication will draw on a handful of tertiary centers. Strict inclusion criteria can shrink the eligible pool quickly. Ask for site-level screening numbers.

    Logistics from the United States

    • Time zone: Belgrade is on UTC+1 (Coordinated Universal Time plus one hour) in winter and UTC+2 in summer, about 6 hours ahead of U.S. Eastern time. That is the closest of the Eastern European and Central Asian countries covered in our guides.
    • Language: Serbian. Confirm the translation requirements for the protocol and informed consent form (ICF).
    • Check the U.S. Department of State travel advisory and current routings.

    Genuine strengths

    Serbia offers a clear, published split between authorization and registration by device class, a single national ethics committee filed at the same time as the agency application, deep trial experience relative to its size, and a European time zone.

    How Latin America compares

    • Same FDA rule: 21 CFR 812.28.
    • Similar structures: Brazil also files ethics and regulatory reviews in parallel. ANVISA (Agência Nacional de Vigilância Sanitária) reviews novel devices at the same time as ethics, and our Brazil hub publishes 6–10 weeks combined.
    • Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination. Argentina’s ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) regulates device clinical investigations under Disposition 969/1997. See our Argentina hub.
    • Time zone: 0–2 hours from U.S. Eastern, compared with about 6 for Belgrade.
    • U.S. continuity: bioaccess® is headquartered in Miami, and its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
    • Trade-offs: Spanish or Portuguese documents and investigational import permits.

    Other country guides: Georgia · Uzbekistan · Kazakhstan · Armenia · Moldova · Ukraine

    Frequently asked questions

    Who approves a device clinical trial in Serbia?

    ALIMS, the Medicines and Medical Devices Agency of Serbia, issues the authorization or registration. The Ethics Committee of Serbia must give a positive opinion.

    Are the agency and ethics applications filed separately?

    No. ALIMS says both are submitted through the Agency at the same time.

    Which devices need full authorization?

    Class IIa devices for long-term use or that are invasive, Class IIb, Class III and active implantable devices. Lower-risk studies use a registration route.

    Will the FDA accept data from Serbia?

    It can. Under 21 CFR 812.28, FDA accepts data from outside the United States from studies run under GCP that it can validate. The decision is made case by case.

    Next step

    Comparing Serbia with a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • Medical Device Clinical Trials in Ukraine: Experience, Wartime Realities, a Regulatory Transition, and How Latin America Compares

    General information, not legal or regulatory advice. Sources were checked on 28 September 2026. bioaccess® does not run studies in Ukraine and is not affiliated with any company named here.

    Ukraine has one of the larger clinical-trial footprints in Eastern Europe, and some device contract research organizations (CROs), including Clinical Accelerator, list it on their coverage maps. If you are a MedTech founder weighing Ukraine for a first-in-human (FIH) or early feasibility study (EFS) in 2026, this page sets out the public facts: the country’s trial experience, the operating environment, a device-regulation transition that is under way, and how a Latin American start compares.

    Operating environment: martial law

    Ukraine has been under martial law since 24 February 2022, introduced by Presidential Decree No. 64/2022. The official legislation portal shows the decree still in force, with a current version dated 25 July 2026. Any sponsor considering Ukraine should build this into site selection, monitoring plans, insurance, investigational device logistics and contingency planning. Also check the U.S. Department of State travel advisory. None of this reflects on Ukrainian investigators. It is simply part of planning responsibly.

    The device regulatory framework and its transition

    • Current framework: medical devices are regulated by technical regulations adopted by the Cabinet of Ministers in 2013. These are Resolution No. 753 for medical devices and Resolution No. 755 for active implantable devices.
    • New technical regulation: on 10 June 2026, the Cabinet of Ministers adopted Resolution No. 759, a new Technical Regulation on Medical Devices that replaces the 2013 regulations. The official portal lists its entry into force on 18 December 2026, but the regulation itself applies from 31 December 2030, with transition provisions.
    • Clinical investigations: the implementation plan attached to Resolution No. 759 includes approving a new procedure for conducting clinical investigations, along with an electronic clinical-investigation system inside a national medical device database due by December 2029.
    • Market surveillance: Resolution No. 759 names the State Service of Ukraine on Medicines and Drugs Control as the market-surveillance authority for medical devices.

    Practical takeaway: device clinical-investigation rules in Ukraine are moving toward a new framework. Get a written opinion from Ukrainian regulatory counsel on the exact filing route and ethics requirements that apply to your study today.

    What is published about timelines

    We found no official, device-specific end-to-end timeline for the current framework in the sources above. Ask for a written calendar and a contingency plan.

    Standards and U.S. data acceptance

    The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study is well designed and well conducted under good clinical practice (GCP), with independent ethics review and informed consent, and FDA can validate the data. That includes onsite inspection if FDA decides one is needed, so factor in the practicality of inspections. The data can support an investigational device exemption (IDE), 510(k), De Novo or premarket approval (PMA) submission. Run the study to ISO 14155, the international GCP standard for device investigations.

    Patients, sites and device experience

    • Population: about 37.9 million (World Bank, 2024).
    • ClinicalTrials.gov (28 September 2026): 2,721 records of all types list a site in Ukraine. Of these, 54 are interventional device records, and none has “device feasibility” as its primary purpose.
    • ClinicalTrials.gov also lists a device study with a Ukrainian site that names Clinical Accelerator as a collaborator (NCT03484780). See our regional comparison.

    Recruitment reality: trial experience is broad, but conditions can change quickly in wartime, and strict inclusion criteria shrink eligible pools anywhere. Ask for current, site-level screening data and a documented backup-site plan.

    Logistics from the United States

    • Time zone: Kyiv is on UTC+2 (Coordinated Universal Time plus two hours) in winter and UTC+3 in summer, about 7 hours ahead of U.S. Eastern time.
    • Language: Ukrainian. Confirm the translation requirements for the protocol and informed consent form (ICF).
    • Check the U.S. Department of State travel advisory before you plan any travel.

    Genuine strengths

    Ukraine has a large population, extensive international trial experience on ClinicalTrials.gov, experienced investigators, and a device framework being modernized along European lines.

    How Latin America compares

    • Same FDA rule: 21 CFR 812.28.
    • Operating environment: the Latin American countries we work in are not under martial law. Check travel advisories for any country you choose, in either region.
    • Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination. Our Brazil hub publishes 6–10 weeks for ANVISA (Agência Nacional de Vigilância Sanitária) plus ethics review.
    • Scale: Brazil (about 212 million people) and Mexico (about 131 million), with 1,170 and 244 interventional device records respectively on ClinicalTrials.gov.
    • Time zone: 0–2 hours from U.S. Eastern.
    • U.S. continuity: bioaccess® is headquartered in Miami, and its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
    • Trade-offs: Spanish or Portuguese documents, investigational import permits, and regulators with differing predictability.

    Other country guides: Georgia · Uzbekistan · Kazakhstan · Armenia · Moldova · Serbia

    Frequently asked questions

    Are device clinical trials still possible in Ukraine?

    ClinicalTrials.gov continues to list studies with Ukrainian sites. Martial law has been in force since February 2022, so plan carefully for logistics, monitoring and contingencies, and take current regulatory advice.

    What regulation governs medical devices in Ukraine?

    For now, the 2013 technical regulations (Cabinet Resolutions No. 753 and No. 755). A new Technical Regulation, Resolution No. 759 of 10 June 2026, applies from 31 December 2030.

    Will there be a new procedure for device clinical investigations?

    Yes. The implementation plan for Resolution No. 759 includes approving a new procedure for conducting clinical investigations.

    Will the FDA accept data from Ukraine?

    It can. Under 21 CFR 812.28, FDA accepts data from outside the United States from studies run under GCP that it can validate, including by onsite inspection if needed. The decision is made case by case.

    Next step

    Need a Latin American option alongside or instead of Ukraine? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • Medical Device Clinical Investigations in Moldova: A 30-Working-Day Clock, a Small Footprint, and How Latin America Compares

    General information, not legal or regulatory advice. Sources were checked on 28 September 2026. bioaccess® does not run studies in Moldova and is not affiliated with any company named here.

    Moldova sometimes comes up when MedTech founders look for fast, lower-cost geographies for a first-in-human (FIH) or early feasibility study (EFS). This page summarizes Moldova’s device clinical-investigation rules as its regulator publishes them, gives an honest picture of the country’s device-trial footprint, and compares it with a Latin American start.

    The pathway, in the regulator’s own words

    A page on the website of Moldova’s Medicines and Medical Devices Agency (AMDM) sets out the legal rules for clinical investigations of medical devices. In summary:

    • Devices without CE marking (the European conformity mark) may be supplied for clinical investigation if they meet the applicable technical regulation and come with the manufacturer’s declaration of conformity.
    • Applicant: the manufacturer or its authorized representative.
    • Before starting, the applicant notifies the Agency. The application must include device data, the clinical investigation plan, and a positive opinion from the National Ethics Committee, plus any other documents the Agency specifies.
    • The Agency issues its opinion within 30 working days of receiving a complete application.
    • During the investigation: device-related complications must be reported to the Agency within 7 working days. A notified modification may be implemented if the Agency issues no negative decision within 30 working days.
    • After completion: the applicant informs the Agency within 30 working days and submits the final report.

    That Agency page also carries older news items, so confirm with local counsel that the text reflects the current law and implementing rules.

    What is published about timelines

    The one official figure is the 30 working days for the Agency’s opinion after a complete application. National ethics review comes before it, since the ethics opinion is part of the application. Ask for a calendar that covers both steps.

    Standards and U.S. data acceptance

    The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study is well designed and well conducted under good clinical practice (GCP), with independent ethics review and informed consent, and FDA can validate the data. The data can support an investigational device exemption (IDE), 510(k), De Novo or premarket approval (PMA) submission. Run the study to ISO 14155, the international GCP standard for device investigations.

    Patients, sites and device experience

    • Population: about 2.4 million (World Bank, 2024).
    • ClinicalTrials.gov (28 September 2026): only 3 interventional device records list a site in Moldova, and none has “device feasibility” as its primary purpose.
    • Moldova does not appear on Clinical Accelerator’s public coverage map. See our regional comparison.

    Recruitment reality: a small population and a thin device-trial record mean you would probably rely on very few centers and investigators. Strict inclusion criteria can shrink the eligible pool quickly. Get screening numbers for your criteria and confirm hands-on experience with similar devices before you commit.

    Logistics from the United States

    • Time zone: Chișinău is on UTC+2 (Coordinated Universal Time plus two hours) in winter and UTC+3 in summer, about 7 hours ahead of U.S. Eastern time.
    • Language: Romanian. Confirm the translation requirements for the plan and the informed consent form (ICF).
    • Check the U.S. Department of State travel advisory and current routings.

    Genuine strengths

    Moldova has a short, legislated regulator clock of 30 working days after a complete application, a single national ethics committee, and rules that reference CE marking and link to European Commission device guidance. For a very focused study with a committed local investigator, those are real advantages.

    How Latin America compares

    • Same FDA rule: 21 CFR 812.28.
    • Device-trial footprint: on ClinicalTrials.gov, Panama has 39 interventional device records, Chile 199 and Brazil 1,170.
    • Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination. Argentina’s ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) regulates device clinical investigations under Disposition 969/1997.
    • Time zone: 0–2 hours from U.S. Eastern.
    • U.S. continuity: bioaccess® is headquartered in Miami, and its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
    • Trade-offs: Spanish or Portuguese documents and investigational import permits. Small Latin American countries carry the same narrow-pool risk.

    Other country guides: Georgia · Uzbekistan · Kazakhstan · Armenia · Ukraine · Serbia

    Frequently asked questions

    Who authorizes device clinical investigations in Moldova?

    The Medicines and Medical Devices Agency (AMDM) does. A positive opinion from the National Ethics Committee must be included with the application.

    How long does the Agency take?

    According to the legal text on the Agency’s website, it issues its opinion within 30 working days of receiving a complete application.

    Can I use a device without CE marking?

    According to the Agency’s page, yes, if it meets the applicable technical regulation and comes with the manufacturer’s declaration of conformity.

    Will the FDA accept data from Moldova?

    It can. Under 21 CFR 812.28, FDA accepts data from outside the United States from studies run under GCP that it can validate. The decision is made case by case.

    Next step

    Comparing Moldova with a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • Medical Device Clinical Trials in Armenia: The Eurasian Economic Union Framework, Local Strengths, and How Latin America Compares

    General information, not legal or regulatory advice. Sources were checked on 28 September 2026. bioaccess® does not run studies in Armenia and is not affiliated with any company named here.

    Armenia appears on the coverage maps of some device contract research organizations (CROs), including Clinical Accelerator’s. If you are a MedTech founder weighing Armenia for a first-in-human (FIH) or early feasibility study (EFS), this page explains how device trials are regulated according to public sources, what Armenia offers, and how a Latin American start compares.

    How device trials are regulated in Armenia

    • Device trials fall under a Eurasian Economic Union rule. Armenia is a member of the Eurasian Economic Union (EAEU). A 2024 Chambers Global Practice Guide chapter by an Armenian law firm says device clinical trials are governed by Decision No. 29 of the Council of the Eurasian Economic Commission (12 February 2016). It also says that, although national law gives the government authority in this area, there were no national government decisions specifically on device clinical trials when the guide was written.
    • Who does the expert work: since Government Decision No. 1795-N (24 November 2022), expert evaluations and inspections for medical devices have been carried out by the Center of Drug and Medical Technology Expertise under the Ministry of Health, according to the center’s own website. The center’s remit includes reviewing clinical-trial protocols and monitoring ongoing trials.
    • How medicines trials are authorized (for context): the Ministry of Health grants permission based on a positive expert opinion from the center and a positive opinion from the Ethics Committee for Clinical Trials. That process is set by Government Decree No. 168-N (28 February 2019). A 2022 law firm overview says the Ministry issues its order within two working days of receiving the ethics committee’s conclusion. Confirm with local counsel whether and how this sequence is applied to devices.

    Practical takeaway: Armenia’s device-trial pathway relies on the regional EAEU rule rather than a detailed national device regulation. That is not necessarily a problem, but it means a sponsor should get a written regulatory opinion on the exact filing route before committing.

    What is published about timelines

    Apart from the two-working-day step for the Ministry order in the medicines process, we found no official end-to-end device timeline. Ask for a written, study-specific calendar.

    Standards and U.S. data acceptance

    The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study is well designed and well conducted under good clinical practice (GCP), with independent ethics review and informed consent, and FDA can validate the data. The data can support an investigational device exemption (IDE), 510(k), De Novo or premarket approval (PMA) submission. Run the study to ISO 14155, the international GCP standard for device investigations, whatever the local minimum.

    Patients, sites and device experience

    • Population: about 3.0 million (World Bank, 2024).
    • ClinicalTrials.gov (28 September 2026): 36 interventional device records list a site in Armenia, and 2 have “device feasibility” as their primary purpose.
    • Clinical Accelerator includes Armenia on its coverage map. See our regional comparison.

    Recruitment reality: in a country of about 3 million, patients for a narrow indication are concentrated in a small number of hospitals. Strict inclusion criteria can shrink the eligible pool quickly, and one center’s priorities can set the pace of enrollment. The same caution applies to small Latin American countries. Ask for site-level screening data.

    Logistics from the United States

    • Time zone: Yerevan is on UTC+4 (Coordinated Universal Time plus four hours), 8–9 hours ahead of U.S. Eastern time.
    • Language: Armenian. Confirm the translation requirements for the protocol and informed consent form (ICF).
    • Check the U.S. Department of State travel advisory and current routings.

    Genuine strengths

    Armenia offers an established regulatory expert center with a trial-monitoring remit, EAEU-level harmonization, and a compact system where investigators and regulators are reachable. For a sponsor with a well-connected local partner and a device that fits the national referral centers, it can work.

    How Latin America compares

    • Same FDA rule: 21 CFR 812.28.
    • Device-specific rules: Brazil regulates device investigations under ANVISA (Agência Nacional de Vigilância Sanitária) RDC 837/2023. Our Brazil hub publishes 6–10 weeks for ANVISA plus ethics review.
    • Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination.
    • Scale: Brazil, Mexico and Argentina together have more than 380 million people (World Bank, 2024).
    • Time zone: 0–2 hours from U.S. Eastern.
    • U.S. continuity: bioaccess® is headquartered in Miami, and its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
    • Trade-offs: Spanish or Portuguese documents and investigational import permits.

    Other country guides: Georgia · Uzbekistan · Kazakhstan · Moldova · Ukraine · Serbia

    Frequently asked questions

    What rule governs device clinical trials in Armenia?

    A 2024 practice guide says device trials fall under Eurasian Economic Commission Council Decision No. 29 (2016), and that there were no specific national government decisions on device trials at the time.

    Which Armenian body reviews device matters?

    The Center of Drug and Medical Technology Expertise under the Ministry of Health carries out expert evaluations for medical devices. The Ministry of Health issues clinical-trial permissions.

    Is there a national ethics committee?

    Yes. For medicines, Armenia has an Ethics Committee for Clinical Trials whose positive opinion is required alongside the expert opinion. Confirm how this applies to devices.

    Will the FDA accept data from Armenia?

    It can. Under 21 CFR 812.28, FDA accepts data from outside the United States from studies run under GCP that it can validate. The decision is made case by case.

    Next step

    Comparing Armenia with a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • Kazakhstan Medical Device Trial Approval: Who Signs Off, What the Rules Say, and How Latin America Compares

    General information, not legal or regulatory advice. Sources were checked on 28 September 2026. bioaccess® does not run studies in Kazakhstan and is not affiliated with any company named here.

    If you searched for “Kazakhstan device trial approval”, you probably want to know who approves an interventional medical device study there, what standards apply, and whether it makes sense for a first-in-human (FIH) or early feasibility study (EFS). This page summarizes the framework from public legal sources and then compares it fairly with a Latin American start.

    Who approves an interventional device trial

    A legal overview published on Legal 500 describes three steps:

    1. Expert review. The National Center for Expertise of Medicines and Medical Devices examines the clinical trial materials and issues a conclusion.
    2. Bioethics review. The Central Commission on Bioethics reviews interventional trials of foreign-produced medicines and devices, as well as trials at two or more centers in Kazakhstan. Local bioethics commissions handle single-center studies, except interventional trials of products made outside Kazakhstan. For a foreign device FIH, plan on the Central Commission.
    3. Permission. The Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare issues the permit and conducts clinical-trial inspections.

    The legal framework

    The same overview lists the main instruments:

    • The Code on Public Health and the Healthcare System (No. 360-VI, 7 July 2020).
    • The Eurasian Economic Union (EAEU) Rules of Good Clinical Practice (Decision No. 79, 3 November 2016) and Kazakhstan’s own good clinical practice (GCP) standard (Order ҚР ДСМ-15, 4 February 2021).
    • ISO 14155 through Eurasian Economic Commission Recommendation No. 17 (4 September 2017) on device trials involving human subjects.
    • The rules for conducting clinical trials and the requirements for clinical sites (Order ҚР ДСМ-248/2020, 11 December 2020).

    Other points from the overview that matter for planning:

    • Site requirements: a medical license, standard operating procedures (SOPs) for trials, suitable equipment or contracted services, GCP-trained staff, and intensive care capability where the protocol requires it.
    • Participant restrictions: interventional trials may not enroll military or law-enforcement personnel, employees of the medical organization where the research takes place, or people in penal institutions.
    • Records: the sponsor and investigator must archive trial documents for 25 years after completion.
    • The overview notes that draft amendments were under public discussion when it was published, so confirm the current text.

    What is published about timelines

    We did not find an official, device-specific end-to-end timeline in the sources above. Ask for a written calendar that covers the expert review, the Central Commission on Bioethics and the Ministry permit.

    Standards and U.S. data acceptance

    The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study is well designed and well conducted under GCP, with independent ethics review and informed consent, and FDA can validate the data. That data can support an investigational device exemption (IDE), 510(k), De Novo or premarket approval (PMA) submission. Kazakhstan’s reference to ISO 14155 fits that expectation. What matters is how the study is actually run.

    Patients, sites and device experience

    • Population: about 20.6 million (World Bank, 2024).
    • ClinicalTrials.gov (28 September 2026): 26 interventional device records list a site in Kazakhstan. None has “device feasibility” as its primary purpose, which suggests early-device experience is still limited.
    • Kazakhstan does not appear on Clinical Accelerator’s public coverage map. See our regional comparison.

    Recruitment reality: with a thin FIH track record, you will depend more heavily on individual investigators’ experience with your device type. Strict inclusion criteria can shrink eligible pools quickly. Verify screening numbers for your criteria at each named site.

    Logistics from the United States

    • Time zone: Astana is on UTC+5 (Coordinated Universal Time plus five hours), 9–10 hours ahead of U.S. Eastern time.
    • Languages: Kazakh and Russian. Confirm the translation requirements for the protocol and informed consent form (ICF).
    • Check the U.S. Department of State travel advisory and current routings.

    Genuine strengths

    Kazakhstan has a codified framework that explicitly references ISO 14155 and EAEU GCP, a defined inspection authority, clear site requirements, and a mid-sized population. For sponsors who also have Eurasian market plans, running work there can be strategically useful.

    How Latin America compares

    • Same FDA rule: 21 CFR 812.28.
    • Early-device track record: on ClinicalTrials.gov, Panama has 5 records with “device feasibility” as their primary purpose, Chile 4 and Brazil 15.
    • Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination. Argentina’s ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) regulates device clinical investigations under Disposition 969/1997. See our Argentina hub.
    • Time zone: 0–2 hours from U.S. Eastern.
    • U.S. continuity: bioaccess® is headquartered in Miami, and its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
    • Trade-offs: Spanish or Portuguese documents and investigational import permits.

    Other country guides: Georgia · Uzbekistan · Armenia · Moldova · Ukraine · Serbia

    Frequently asked questions

    Who issues permission for a device trial in Kazakhstan?

    The Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare issues the permit. It relies on a conclusion from the National Center for Expertise of Medicines and Medical Devices and a bioethics opinion.

    Which ethics body reviews a foreign device trial?

    For interventional trials of foreign-produced devices, the Central Commission on Bioethics reviews the study, according to the published legal overview.

    Does Kazakhstan follow ISO 14155?

    Yes. A Eurasian Economic Commission recommendation on device good clinical practice, based on ISO 14155, is part of the framework.

    Will the FDA accept data from Kazakhstan?

    It can. Under 21 CFR 812.28, FDA accepts data from outside the United States from studies run under GCP that it can validate. The decision is made case by case.

    How long does approval take?

    We found no official device-specific figure. Ask for a written calendar.

    Next step

    Comparing Kazakhstan with a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.