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Category: First-in-Human

  • 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.

  • 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® treats as study-specific, timed to each committee’s meeting schedule, the planning 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

  • 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

  • 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.

    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: Uzbekistan

    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®.

  • Medical Device Clinical Trials in Uzbekistan: The 2026 Rules, 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 Uzbekistan and is not affiliated with any company named here.

    Uzbekistan is newer to device trials and is drawing attention from MedTech sponsors. ClinicalTrials.gov already lists device studies with Uzbek sites that are explicitly labelled first-in-human (FIH), such as NCT07811024 and NCT06700226. If you searched for “clinical trials Uzbekistan medical device”, this page covers the new rules, what the country offers, and how a Latin American FIH compares.

    The 2026 device-trial regulation

    The Minister of Health approved a Regulation on the procedure for conducting clinical trials of medical equipment. It was registered by the Ministry of Justice on 7 January 2026 (No. 3746) and published in the state language, Uzbek. According to the legal news service Norma.uz, it entered into force on 26 February 2026. Summaries by Norma.uz and a Tashkent law firm describe these main points:

    • Exemptions from clinical trials for registration: Class I (low-risk) devices, in vitro diagnostics prequalified by the World Health Organization (WHO) or registered with WHO support, devices already clinically tested in Uzbekistan, and, per the law firm, some devices with a proven record of safe use.
    • Who decides: an Expert Council of the Ministry of Health decides whether a trial is required, on the recommendation of the Center for the Safety of Pharmaceutical Products.
    • Minimum size: trials under the regulation must enroll at least 20 subjects, scaled to the device’s risk class, and multi-center designs are possible for higher-risk devices.
    • Parallel review: under the medical device registration rules adopted in November 2025, laboratory testing and specialized expert review run at the same time. An independent expert checks the clinical site, the trial design and the assessment methods.
    • Ethics: a trial cannot start without a positive opinion from the designated ethics committee. Written informed consent is required.
    • Sponsor duties: providing the device, insuring subjects, monitoring and auditing, and reporting adverse events.

    An important caveat for FIH planning: the regulation is written around state registration in Uzbekistan. How it applies to a foreign sponsor’s small FIH protocol that is not aimed at Uzbek registration, including the 20-subject minimum, is something to confirm in writing with local regulatory counsel before you commit.

    What is published about timelines

    We found no official end-to-end timeline for device trials under the 2026 regulation. Because the rules are new, treat any quoted clock as an estimate until you have 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. Plan to run to ISO 14155, the international GCP standard for device investigations, whatever the local minimum requires.

    Patients, sites and device experience

    • Population: about 36.4 million (World Bank, 2024).
    • ClinicalTrials.gov (28 September 2026): 23 interventional device records list an Uzbek site, and 3 have “device feasibility” as their primary purpose. The footprint is small but growing.
    • Clinical Accelerator lists Uzbekistan on its coverage map and names a country lead there.

    Recruitment reality: a large national population does not mean a large eligible pool at the sites you will actually use. Strict inclusion criteria and referral patterns concentrated in a few hospitals can slow enrollment. Ask for site-level screening numbers for your criteria.

    Logistics from the United States

    • Time zone: Tashkent is on UTC+5 (Coordinated Universal Time plus five hours), 9–10 hours ahead of U.S. Eastern time.
    • Language: the regulation is published in Uzbek. Confirm the translation requirements for the protocol and informed consent form (ICF).
    • Check the U.S. Department of State travel advisory and current flight routings before you plan visits.

    Genuine strengths

    Uzbekistan has a sizeable population, a brand-new device-trial rulebook with defined exemptions and a parallel-review design, and FIH device studies already on ClinicalTrials.gov. For sponsors who want an emerging geography with engaged investigators, it is worth evaluating.

    How Latin America compares

    • Same FDA rule: 21 CFR 812.28.
    • Established pathways: Brazil’s ANVISA (Agência Nacional de Vigilância Sanitária) regulates device investigations under RDC 837/2023, and 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.
    • Time zone: 0–2 hours from U.S. Eastern, compared with 9–10 for Tashkent.
    • 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: Kazakhstan

    Frequently asked questions

    Does Uzbekistan have rules for medical device clinical trials?

    Yes. A Ministry of Health regulation on clinical trials of medical equipment was registered on 7 January 2026 (No. 3746) and took effect on 26 February 2026.

    Who decides whether a device trial is needed in Uzbekistan?

    An Expert Council of the Ministry of Health decides, on the recommendation of the Center for the Safety of Pharmaceutical Products. A positive ethics committee opinion is required before the trial starts.

    Is there a minimum number of patients?

    Published summaries say trials under the regulation must enroll at least 20 subjects. Confirm how this applies to a small FIH protocol that is not aimed at Uzbek registration.

    Will the FDA accept data from Uzbekistan?

    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

    Weighing Uzbekistan against a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • Best countries for a structural heart early feasibility study: a practical shortlist

    Sponsors searching for the best countries for a structural heart early feasibility study usually want a ranked list of flags. The useful answer is a short list of decision filters, then a country shortlist that survives those filters. A structural heart early feasibility study (EFS) is a small, early human investigation of a novel cardiac device before a powered pivotal trial. Getting the geography wrong costs a protocol amendment and a missed financing window.

    I am Julio Martinez-Clark, CEO of bioaccess®. This brief is for U.S. and European MedTech teams scoping structural heart EFS outside the United States. It complements the Early Feasibility Studies pillar, the EFS vs pivotal sequencing note, and the LATAM FIH startup clock. Public case patterns on bioaccessla.com (for example Axoft’s Panama first-in-human corridor for a novel implant class, and ReGelTec’s OUS path into later U.S. pivotal work) show the geography pattern — they are not structural-heart claims unless the live case study says so.

    What “best country” actually means for structural heart EFS

    Best is not cheapest. For structural heart, best usually means:

    • Ethics and investigation authorization that can start a small cohort on a founder’s runway
    • Hospitals with real cardiac imaging, cath-lab or hybrid-OR capacity, and a principal investigator who already implants in the same anatomic neighborhood
    • Import rules that let an investigational device clear customs without a commercial registro sanitario
    • A data posture that can support a later U.S. Investigational Device Exemption (IDE) or marketing file under 21 CFR 812.28 when the study is run under ISO 14155

    Filter 1 — Regulator and ethics desks

    Separate the ethics committee from the national investigation desk. Mixing them is how first patient slips a cycle. In Latin America the planning bands bioaccess® publishes for device FIH / EFS work are roughly ethics review timed to each committee’s meeting schedule in several corridors, with national investigation authorization commonly in a 1–3 month band after a complete dossier. Confirm every form on the agency’s current page before you file.

    Country examples sponsors keep shortlisting for early device work (not a ranking, a working set): Colombia (INVIMA investigation path plus Comité de Ética en Investigación), Panama (MINSA / CNBI corridor used for several public FIH stories), El Salvador (fast startup band on the published El Salvador FIH cost and timeline page), Chile (ISP investigation authorization is not the same as Exempt Decree No. 25 commercial registro — see the Chile ISP clinical trial path), Mexico (COFEPRIS), Brazil (ANVISA), and Argentina (ANMAT). Pick from that set with the filters below, not from a tourism map.

    Filter 2 — Procedure infrastructure

    Structural heart EFS fails quietly when the site cannot support the implant or repair workflow. Before you fall in love with a regulator timeline, confirm:

    • Echo, CT, and fluoro capacity on the study schedule
    • Hybrid OR or cath-lab time that matches your enrollment plan
    • Cardiac anesthesia and ICU backup for the risk class
    • A principal investigator with recent volume in the adjacent commercial procedure (TAVR adjacency is not automatic qualification for a novel mitral or tricuspid device)

    Filter 3 — Import and holder rules

    Investigational import is not market clearance. Keep the trial file on the investigation track. If you also need commercial registration later, that is a separate Market Access / Importer of Record conversation — start at LATAM market access and Importer of record across Latin America.

    Filter 4 — FDA evidence role

    Write one sentence into the protocol: what this EFS must prove for the next U.S. milestone. Foreign clinical data can be considered under 21 CFR 812.28 when the study is inspectable and documented under good clinical practice. Acceptance remains FDA’s decision. Design the evidence drawer at study start: protocol, consent, monitoring, source traceability, and a clinical study report structure.

    Practical shortlist pattern

    For a first structural heart EFS with a small cohort and a U.S.-anchored later file, sponsors often land on one primary Latin American country plus one backup site in the same or a second country. Panama and Colombia appear repeatedly in public FIH narratives for novel implants because ethics and site activation can move inside a founder’s year. El Salvador shows up when startup calendar pressure is the binding constraint. Chile is a rigor option when the team wants ISP investigation discipline and already understands Decree 25 is a commercial track, not the trial track. Australia remains a peer comparator for some teams (rebate math, English, timezone); the honest ops comparison lives on Latin America vs Australia for FIH — use it, do not invent a rebate for Latin America that does not exist.

    Operator checklist before you lock geography

    1. Confirm EFS-first is the right sequencing call (see the EFS vs pivotal brief).
    2. Name the procedure infrastructure the site must already have.
    3. Name primary and backup countries with separate ethics and investigation owners.
    4. Write the 21 CFR 812.28 evidence-role sentence into the protocol.
    5. Keep commercial registro and Importer of Record work off the investigational clock unless the study truly needs a registered comparator device.

    bioaccess® runs structural heart and other early device EFS work as a First-in-Human CRO with U.S. regulatory anchoring and Latin American execution. Bring the device class, the implant workflow, and the financing date — we will return a country shortlist that survives the four filters.

  • Early feasibility vs pivotal trial: which comes first for a medical device?

    Sponsors keep asking whether an early feasibility study or a pivotal trial comes first as if the answer were a preference. It is not. For a novel medical device, an early feasibility study (EFS) generally comes before a pivotal trial because the two studies answer different questions.

    I am Julio Martinez-Clark, CEO of bioaccess®. This is the sequencing brief I reuse when a founder wants to jump straight to a powered pivotal. It sits next to the live Early Feasibility Studies pillar, the LATAM FIH startup clock, and the FDA acceptance of Latin American data note. It is not a quote and not legal advice.

    One-sentence answer

    An early feasibility study comes first when clinical safety, function, or design finality is still open. A pivotal trial comes later to collect definitive safety and effectiveness evidence for a specified intended use. Skip the EFS only when nonclinical evidence already closes those unknowns and the device design is frozen.

    What each study is built to answer

    An EFS is a limited clinical investigation conducted early in development. Enrollment is small. The job is initial clinical safety and feasibility evidence — proof the device can be used in humans without a surprise failure mode. The U.S. Food and Drug Administration (FDA) Early Feasibility Studies Program is the U.S. framing for that IDEA under an Investigational Device Exemption (IDE) in 21 CFR Part 812.

    A pivotal study is sized and powered for definitive endpoints. It assumes the device design is stable, the primary endpoint is known, and the statistical analysis plan can be written with real assumptions. If you are still learning what the right endpoint is, a pivotal protocol will be mis-scoped.

    Four decision nodes

    1. Risk class and novelty. Higher-risk implants and first-in-class mechanisms carry more human uncertainty. When nonclinical data alone cannot justify definitive effectiveness endpoints, EFS-first is the honest path.

    2. Preclinical maturity and design finality. Is the GLP / bench / animal package enough to characterize primary safety risks? Is the device design frozen? If either answer is no, stay in EFS.

    3. Funding runway. Pivotal enrollment is larger and slower. If the next financing round needs human evidence this year, a small EFS can deliver proof-of-principle without burning the pivotal budget early. That is planning math, not a guarantee.

    4. Intended U.S. pathway. Map the study to the 510(k), De Novo, or Premarket Approval (PMA) evidence role you actually need. EFS does not replace pivotal evidence. A well-designed EFS can refine endpoints, validate risk controls, and feed the assumptions your later statistical analysis plan will use.

    When a direct pivotal path can make sense

    Lower-risk devices with a frozen design, a complete nonclinical package, and enough runway for a powered study can sometimes go straight to pivotal (or a traditional feasibility study if a thin clinical gap remains). Adding an EFS stage in that case delays marketing authorization without generating meaningfully new information.

    How Latin America fits the EFS step

    Many U.S. MedTech teams run the early human evidence step outside the United States, then bring a cleaner package into the U.S. IDE or marketing file. Foreign clinical data can be considered under 21 CFR 812.28 when the study is inspectable and conducted under good clinical practice. ISO 14155 is the device GCP standard we design to. Acceptance is still FDA’s call per submission — there is no automatic transfer.

    In Latin America, ethics-committee review for device FIH / EFS work depends on each committee’s meeting schedule, and in-country investigation authorization often follows in roughly 1–3 months depending on country and dossier quality. Those are experience-based ranges from bioaccess® programs since 2010, not a promise for your protocol. The startup clock page keeps the country bands in one place.

    Documentation to lock before first patient

    • Protocol with an explicit evidence-role statement (what this study must do for the next regulatory or financing milestone)
    • Informed consent aligned to the local ethics committee
    • Monitoring and quality plan with deviation tracking
    • Data management plan with source-document traceability
    • Clinical study report structure and analysis framework ready at study start, not after database lock

    Operator checklist

    1. Write answers to the four decision nodes in one page.
    2. List preclinical gaps before you pick study type.
    3. Draft the evidence-role sentence your protocol will carry.
    4. If EFS-first, choose the country corridor for ethics speed and cardiac or procedure infrastructure — not for tourism.
    5. If you already have human feasibility evidence and a frozen design, stop debating EFS and scope the pivotal honestly.

    Talk with bioaccess® when you need the sequencing call tied to a concrete FIH or EFS country plan and an FDA-anchored evidence drawer.

  • Why Chile’s ISP Regulates Medical Device Clinical Trials Differently From Drug Trials, and Where It Doesn’t

    Sponsors comparing Latin American countries often hear a shortcut about Chile: device studies only need ethics approval and an import permit, and the regulator stays out of the way. That shortcut is out of date. Chile’s Instituto de Salud Pública (ISP) authorizes both drug trials and device trials. The real differences sit somewhere else: in which agency inside ISP handles the file, which rules were written with devices in mind, and how settled the device guidance is.

    The short version

    • Same legal gate. Since Ley 20.850 (2015), Código Sanitario Article 111 A requires an ISP “autorización especial para uso provisional con fines de investigación” for pharmaceutical products and medical devices (“elementos de uso médico”) used in research on humans.
    • Ethics first. The ISP application comes after approval under Article 10 of Ley 20.120, which requires a favorable report from an accredited Comité Ético Científico (CEC).
    • Different agencies. Drugs go through ISP’s Agencia Nacional de Medicamentos (ANAMED). Devices go through the Agencia Nacional de Dispositivos Médicos (ANDIM).
    • Different rulebooks. Several older Chilean research instruments, including Norma Técnica 57, were written for medicines. The device route rests mainly on the Código Sanitario and device-specific ISP guidance, and some of that guidance is still being finalized.

    Two agencies inside one institute

    ISP is Chile’s national regulator for medicines and medical devices. Drug work, including ISP’s clinical studies pages for investigational medicines, sits under ANAMED. Device work sits in ANDIM. On its agency page, ISP describes ANDIM as responsible for the safety and performance of medical devices, including in vitro diagnostic devices (IVDs), through authorization, control, inspection and surveillance across the whole device life cycle.

    A standalone device goes to ANDIM. A combination product may involve both.

    What is the same for drug and device trials

    The CEC review comes first

    Ley 20.120 is Chile’s law on scientific research in human beings. Its regulation, Decreto Supremo (DS) 114 of 2010, as amended in 2013, requires every study to have “una revisión e informe favorable de un Comité Ético Científico acreditado.” For multicenter studies, one accredited committee does the scientific and ethical review, and each site adds a local feasibility evaluation. Under DS 114 Article 18, the CEC must issue its report within 45 days of submission, a deadline it can extend once by 20 days for stated reasons.

    Article 111 A then makes the order explicit: the ISP application is filed “previa aprobación conforme a lo dispuesto en el artículo 10 de la ley N°20.120,” with the protocol, the informed consent form, the insurance policy and any other document the regulation requires. For devices and drugs alike, the CEC letter comes before the ISP file.

    ISP issues a provisional-use authorization

    Article 111 A says the authorization is required for any drug or medical device used in research that lacks a sanitary registration, or that has one but will be used differently from how it was registered. The authorization lasts up to one year and can be renewed. The product can only be used as the authorization allows, and ISP must keep a public registry of the research it authorizes.

    Shared obligations during and after the study

    • Safety reporting: adverse events go to ISP and the CEC, under pharmacovigilance rules for drugs and technovigilance rules for devices (Article 111 B).
    • Post-trial access: the authorization holder must continue treatment at no cost while it remains useful, as described in the protocol (Article 111 C). Our note on post-trial access in Chile under Ley 20.850 covers how this works in practice.
    • Site accreditation and inspection: research centers must be accredited by ISP, which can inspect protocols, consent, GCP compliance and safety reporting (Article 111 D).
    • Liability and insurance: authorization holders are liable for harm caused by the research (Article 111 E) and must carry civil liability insurance under the applicable regulation (Article 111 F). For devices, Article 111 F says a supreme decree sets the device classes for which insurance is mandatory. Our note on Chile clinical trial insurance covers the ethics-committee side.
    • Institutional sign-off: under DS 114 Article 10 bis, the director of each research site authorizes the study within 20 business days of the favorable CEC review and, where applicable, the ISP authorization.

    Where drug and device trials genuinely differ

    The older rulebook was written for medicines

    Much of what sponsors read about Chilean trial rules comes from instruments that name drugs, not devices:

    • Código Sanitario Article 99 lets ISP provisionally authorize the use of pharmaceutical products without registration for clinical trials, subject to a favorable CEC report.
    • DS 114 Article 7 gives ISP the power to “autorizar el uso de medicamentos con o sin registro sanitario, con fines de investigación científica y ensayos clínicos.” The article speaks of medicines only.
    • Norma Técnica 57, approved by Ministry of Health (MINSAL) Exempt Resolution 952 of 2001, is titled “Regulación de la ejecución de ensayos clínicos que utilizan productos farmacéuticos en seres humanos.”

    For devices, the legal basis is Código Sanitario Article 111 A. It is backed by Article 111 letter g, which says ISP must authorize the use and disposal of the medical elements covered by Article 111, and by DS 825 of 1998, the regulation on the control of medical-use products and elements. A drug-trial checklist will not map cleanly onto a device file.

    What ISP looks at

    For drugs, ISP has said publicly that it assesses the investigational medicine “teniendo a la vista el protocolo del ensayo clínico, el manual del investigador y certificaciones” such as Good Clinical Practice (GCP) and Good Manufacturing Practice, and decides by reasoned resolution (ISP, 2020).

    For devices, ISP ran a public consultation from 5 June to 5 July 2026 on a guide explaining how to organize an application for provisional-use authorization of a medical device in clinical research in humans. Check whether the final guide has been published before you assemble your file. Until it is, build the dossier around ISO 14155:2020, the international standard for good clinical practice in medical device investigations: the clinical investigation plan, the investigator’s brochure, and the risk analysis behind them. Then confirm the exact document list with ANDIM.

    A possible exemption for low-risk devices

    Article 111 A lets MINSAL exempt, by supreme decree, “los elementos de uso médico cuya utilización no conlleve un riesgo relevante para las personas.” Article 111 A offers no equivalent carve-out for drugs. We have not confirmed that an exemption decree is in force, so treat this as something to check for your device, not an assumption.

    Commercial registration status plays a different role

    Most medical devices in Chile still do not need an ISP sanitary registration to be sold. ISP’s own registration page lists a short set of products under mandatory registration: latex gloves, condoms, sterile hypodermic needles and syringes, portable automated external defibrillators, HIV in vitro diagnostic (IVD) tests, immunohematology reagents and IVD reagents for screening blood donations. Exempt Decree 25 of 2026 adds 39 more. Registration becomes mandatory for 13 of them 24 months after publication (19 March 2028) and for the other 26 after 36 months (19 March 2029). The decree governs manufacture, import, sale and distribution, and it does not mention clinical investigation. An investigational device therefore does not need a registro sanitario. It needs the Article 111 A authorization. Our Chile ISP clinical-trial path for medical devices explains how to keep the trial file and the Decree 25 registration file on separate timelines.

    What this means for your timeline

    Because the CEC review comes before the ISP application, a Chilean device study runs in sequence: ethics review, then ISP authorization and investigational import, then the site director’s authorization. The primary sources set some of the clocks: 45 days for the CEC report (extendable once by 20 days) and 20 business days for the site director. For the ISP step, our Chile ISP device trial page plans on about 30 business days after a complete package, to be confirmed at filing. For overall site activation, our phase-by-phase site activation timeline guide shows that, in our recent plans, ethics and regulatory approval of a complete submission in the fast-corridor countries, Chile included, took about 1 to 3 months, and activation from protocol synopsis to first patient about 8 to 9 months. Treat both as planning figures, not guarantees.

    So the fair comparison with the US is not “no regulator review in Chile.” It is an ISP device authorization that follows an accredited CEC review, with legal deadlines on the ethics and site-director steps.

    Chile, IMDRF and using the data elsewhere

    ISP says Chile has been an affiliate member of the International Medical Device Regulators Forum (IMDRF) since November 2023. Affiliate status signals regulatory convergence. It does not mean ISP accepts another regulator’s decision in place of its own trial authorization.

    If you plan to use Chilean data outside Chile, design the study for that from day one. Under 21 CFR 812.28, the US Food and Drug Administration (FDA) can accept a foreign clinical investigation that supports an investigational device exemption (IDE) or a marketing submission, if the study was well designed, well conducted and followed GCP, including independent ethics committee review and informed consent, and FDA is able to validate the data, by inspection or other means if needed. In Europe, the EU Medical Device Regulation (MDR) 2017/745 sets out clinical investigation requirements in Article 62 and Annex XV. Your notified body will judge how data generated outside the EU fits your clinical evaluation.

    Checklist for device sponsors considering Chile

    • Confirm the file goes to ANDIM, and flag early any drug or biologic component.
    • Choose a lead accredited CEC and each site’s local review route before you finalize the protocol.
    • Prepare the Article 111 A package: protocol, Spanish informed consent form, insurance policy, and ISO 14155-aligned device documents.
    • Check whether ISP has published the final device provisional-use guide, and whether any low-risk exemption or insurance-class decree applies to your device.
    • Plan investigational import alongside the ISP step, not after it.
    • Keep any Decree 25 commercial registration work on a separate timeline.

    Frequently asked questions

    Does Chile’s ISP approve medical device clinical trials, or only the import?

    ISP does more than clear the import. Código Sanitario Article 111 A, added by Ley 20.850 in 2015, says drugs and medical devices used in research on humans need a special provisional-use authorization from ISP. That applies when the device has no sanitary registration, or when it has one but will be used differently from how it was registered.

    Does the ethics committee or ISP go first in Chile?

    The ethics committee goes first. Under Article 111 A, the sponsor files with ISP only after the study has been approved under Article 10 of Ley 20.120, which requires a favorable report from an accredited Comité Ético Científico (CEC). The application must include the protocol, the informed consent form and the insurance policy.

    Does Norma Técnica 57 apply to medical device trials?

    Not on its face. Norma Técnica 57, approved by Ministry of Health Exempt Resolution 952 of 2001, regulates clinical trials that use pharmaceutical products in humans. The device rules come from Código Sanitario Articles 111 and 111 A, Decreto Supremo 825 of 1998 and ISP guidance. Confirm current requirements with ISP.

    Does an investigational device need a registro sanitario before a trial in Chile?

    No. Commercial sanitary registration and research use are separate. Article 111 A covers devices that do not have a registration, which is why the trial needs ISP’s provisional-use authorization instead. Exempt Decree 25 of 2026 widens commercial registration but says nothing about clinical investigations.

    Can data from a Chile device study support an FDA or EU submission?

    It can, if the study is designed for that. Under 21 CFR 812.28, FDA can accept a well-designed, well-conducted foreign study that followed good clinical practice, including independent ethics review and informed consent, if FDA can validate the data. For Europe, plan against EU MDR Article 62 and Annex XV. Acceptance is decided case by case.

    This article is general information, not legal advice. Requirements change, and ISP’s device research guide was under public consultation in 2026. Verify current requirements with ISP and your CEC before filing.

    Considering Chile for a device study? bioaccess® can map feasibility, CEC routes, ISP authorization and site access for your protocol. Contact bioaccess® at bioaccessla.com to start.

  • Karla Alfaro, MD: El Salvador Cervical-Screening Investigator Is Not the CRO

    Names and roles cited from live ClinicalTrials.gov records NCT07461818, NCT06815939, NCT07538050, and NCT07232355 (overall-official, central-contact, and location-contact fields), checked 27 September 2026. Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current El Salvador and U.S. regulatory and ethics rules with qualified advisers. We do not reprint emails or phones and do not add affiliations beyond the registry strings cited here.

    If you searched Karla Alfaro MD El Salvador, Dr Karla Alfaro clinical trial, Karla Alfaro Basic Health International, or “go direct to Karla Alfaro,” you followed investigator and contact strings ClinicalTrials.gov publishes. The work visible on those records is cervical cancer screening and pre-cancer treatment in El Salvador. A named principal investigator is not a first-in-human (FIH) medical-device contract research organization (CRO), and a personal reply is not the operator of the national file.

    bioaccess®’s position is simple and it is not adversarial: the investigator is part of the site. The CRO still owns the Superintendencia de Regulación Sanitaria (SRS) and Comité Nacional de Ética de la Investigación en Salud (CNEIS) filings, investigational import, insurance, ISO 14155 monitoring, and the 21 CFR 812.28 package.

    Registry roles, copied as listed (checked 27 September 2026)

    Registry count: ALL 4 / DEVICE 2. All four records are listed as RECRUITING.

    Record Sponsor Type / intervention Status Role(s) listed for Karla Alfaro
    NCT07461818 (POC) Basic Health International, Inc. Interventional; IRIS™ Thermal Ablation Device (DEVICE); estimated 5,000 RECRUITING Overall PRINCIPAL_INVESTIGATOR (affiliation Basic Health International, Inc.), shared with Rachel Masch, MD; central CONTACT
    NCT06815939 (OPTICS) DL Analytics Interventional screening; interventions include the EVA System (DEVICE); estimated 10,000 RECRUITING Overall PRINCIPAL_INVESTIGATOR (affiliation Basic Health International, Inc.), shared with David Levitz, PhD (DL Analytics); site PRINCIPAL_INVESTIGATOR and CONTACT at “Ministerio de Salud,” San Salvador
    NCT07538050 (SCALE AIM 2) The Cleveland Clinic Interventional; same-day screen and treat (BEHAVIORAL); estimated 1,000 RECRUITING Site PRINCIPAL_INVESTIGATOR and CONTACT (listed as “Karla Alfaro, MD, MPH”) at “Ministry of Health Clinics,” San Salvador
    NCT07232355 (PROGRESS) Atila Biosystems Inc. Observational; estimated 5,000 RECRUITING (see note) Site CONTACT at Basic Health International, San Salvador

    Notes from the records themselves: OPTICS lists an estimated primary completion of 31 July 2026, which has passed, and an estimated study completion of 31 December 2026. PROGRESS lists estimated completion in June 2026, which has passed, and was last updated 19 November 2025, so its recruiting status is unconfirmed. SCALE AIM 2 started 16 April 2026. POC started 1 January 2026. None of the four records calls itself first-in-human, and none names a CRO.

    Facility page for the site she is most often tied to on the registry: Basic Health International San Salvador. The Ministry of Health locations are listed only as generic strings (“Ministerio de Salud,” “Ministry of Health Clinics”), so we do not name a specific clinic.

    The contact is the contact. The CRO is the operator.

    What a named investigator can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol fits an existing service.
    • Share local research rules and how the cases would physically run.
    • Estimate local visit, staffing, and procedure effort for the cases they will run.

    What a contact is not built to own for an investigational device:

    • SRS authorization and the CNEIS packet, filed in parallel on the national digital platform.
    • Investigational import and device accountability — see importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a premium here.
    • ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF).
    • The 21 CFR 812.28 package. Eligibility is not clearance, and a site agreement does not produce it.

    Going direct is how you confirm a room and a person. It is not how you open an investigational file.

    Regulator, ethics, timeline, and cost (published figures)

    These lines are copied from the published bioaccess® post El Salvador first-in-human cost and timeline vs the United States, not re-averaged here:

    • The live El Salvador hub already publishes a 30–60 day study-startup band via parallel review by the Superintendencia de Regulación Sanitaria (SRS) and the Comité Nacional de Ética de la Investigación en Salud (CNEIS) on one digital platform. That band is investigation authorization plus ethics — not commercial registro.
    • SRS replaced the former Dirección Nacional de Medicamentos (DNM) in August 2024. Ethics stays centralized at CNEIS.
    • The El Salvador hub already publishes roughly 60% cost savings versus equivalent U.S. programs, plus a dollarized (U.S. dollar) economy. That is orientation from the country page, not a formal study for your device.

    Ask for a study-specific calendar before you put a single date on a board slide. A site email is not an SRS authorization. Trial authorization and commercial registro are separate files; see CNEIS/SRS trial authorization vs registro.

    All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Foreign clinical data can be eligible for U.S. Food and Drug Administration (FDA) submission and review under 21 CFR 812.28. Eligibility is not clearance or approval. See OUS FIH and FDA IDE.

    Not a critique of the investigator

    Karla Alfaro, MD is a named principal investigator on public cervical-screening and pre-cancer treatment records in El Salvador. That is evidence of a person doing registered research, not a punchline. Roles are as listed. Hire the operator. Activate a site only if it fits.

    Colombia note

    Colombia remains a strong market-access geography and a historical first-in-human geography for bioaccess®. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. We pick the country the device needs.

    Frequently asked questions

    Can I email Karla Alfaro, MD directly about a device study?

    You can try through whatever channel the public registry exposes. A named investigator can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your SRS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager.

    What roles does ClinicalTrials.gov show for her?

    Overall PRINCIPAL_INVESTIGATOR on NCT07461818 and NCT06815939; central CONTACT on NCT07461818; site PRINCIPAL_INVESTIGATOR and CONTACT on NCT06815939 and NCT07538050; site CONTACT on NCT07232355.

    Did bioaccess® run any of these studies?

    No public bioaccess® page says so, and the records do not name a CRO. We will not invent that claim.

    Next step

    Start as the operator: contact bioaccess® or First-in-Human CRO. Country system: clinical trials in El Salvador. Facility sibling: Basic Health International San Salvador.