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  • ANVISA confirms academic medical device studies in Brazil can skip regulatory review: what ANVISA Protocol 2025289179 and RDC 837/2023 mean for sponsors

    ANVISA confirms academic medical device studies in Brazil can skip regulatory review: what ANVISA Protocol 2025289179 and RDC 837/2023 mean for sponsors

    Originally published March 18, 2026. Rebuilt and updated June 20, 2026 with verbatim primary-source quotes from ANVISA Protocol 2025289179 and a dedicated section on the parallel importation authorization process.

    On December 9, 2025, ANVISA’s General Office of Technology Products for Health (GGTPS) issued a written clarification — Protocol No. 2025289179, signed by ANVISA officer Rafaela de Lima Avelino — confirming that strictly academic, non-commercialization clinical studies with medical devices can proceed in Brazil without prior ANVISA regulatory review. The clarification applies regardless of device risk class, meaning Class III and Class IV investigational devices qualify for this pathway if the study protocol explicitly excludes any intent to pursue Brazilian commercialization. Ethics Committee approval through CEP/CONEP remains required, but no ANVISA dossier is filed. For MedTech sponsors designing first-in-human (FIH) programs and evaluating where to run their earliest clinical evidence, this confirmation meaningfully changes the Brazil equation.

    What ANVISA’s December 9, 2025 protocol actually says

    ANVISA Protocol 2025289179 was issued in response to a direct query about the scope of regulatory oversight for academic, non-commercialization device studies under Brazilian law. The GGTPS (Gerência Geral de Tecnologia de Produtos para a Saúde) response confirmed the following position:

    Clinical investigations involving medical devices that are conducted exclusively for academic or scientific purposes — and that carry no present or prospective intent for commercialization in the Brazilian market — are not subject to prior ANVISA regulatory review under RDC 837/2023. Such studies require only Ethics Committee review and approval through the CEP/CONEP system, in line with the framework established under Lei 14.874/2024 and Decreto 12.651/2025.

    ANVISA’s verbatim language in the response (original Portuguese, with translation):

    “São passíveis de anuência emitida pela Anvisa apenas as investigações clínicas para dispositivos médicos cujo objetivo seja solicitar o registro do produto na Anvisa. Desta forma, em sendo o estudo realizado em ‘caráter estritamente acadêmico/científico e não possui finalidade de registro sanitário’ então é dispensável o atendimento a RDC supracitada.”

    Translation: “Only clinical investigations for medical devices whose objective is to request product registration with Anvisa are subject to consent issued by Anvisa. Therefore, if the study is carried out in a ‘strictly academic/scientific character and does not have the purpose of sanitary registration,’ then compliance with the aforementioned RDC is dispensable.”

    The protocol makes explicit that this exemption from pre-study ANVISA review applies across all device risk classes. A Class III or Class IV investigational device used in a study that meets the academic, non-commercialization criteria is treated the same as a lower-risk device for purposes of ANVISA pre-approval — the risk class does not trigger mandatory ANVISA review in this pathway.

    This is a significant regulatory clarification because the text of RDC 837/2023 itself, read in isolation, can create ambiguity about whether the exemption extends to higher-risk devices. Protocol 2025289179 resolves that ambiguity directly, in writing, from the responsible ANVISA directorate.

    Why this matters for Class III and IV device studies

    The prevailing assumption among many MedTech legal and regulatory teams has been that ANVISA review is categorically required before any clinical investigation of a Class III or IV device in Brazil, full stop. Protocol 2025289179 clarifies that this assumption is incorrect when the study is academic and non-commercialization in nature.

    The practical implications are substantial. A sponsor developing a novel implantable device, an active implantable device, a life-sustaining device, or any other product that falls into Brazil’s higher risk classifications can — provided the study protocol is correctly constructed — conduct a first-in-human study at a Brazilian academic medical center under CEP/CONEP review alone. No ANVISA Investigational Device Exemption equivalent dossier. No ANVISA review timeline. No ANVISA fee.

    For sponsors whose Brazilian clinical data will be used to support an FDA Investigational Device Exemption (IDE) or CE Mark application — and who have no immediate intent to pursue Brazilian ANVISA registration — this pathway keeps the regulatory burden proportionate to the study’s actual purpose.

    The distinction that triggers the exemption is not the device class. It is the study’s purpose. If the protocol is academic and the sponsor’s intent is non-commercialization in Brazil, the exemption applies.

    The four reinforcing primary sources

    The ANVISA clarification in Protocol 2025289179 does not stand alone. Four primary sources together form a coherent legal and regulatory basis for the CEP-only pathway in academic device studies.

    RDC 837/2023 — Brazilian Medical Device Clinical Investigation Regulation

    RDC 837/2023 is ANVISA’s operative regulation governing clinical investigations with medical devices. Article structures within the regulation define the scope of mandatory pre-study ANVISA review and carve out studies of a purely academic or scientific nature from that mandatory pathway. The regulation does not itself specify a risk-class threshold for the academic exemption, which is what created interpretive uncertainty — and which Protocol 2025289179 now resolves by confirming the exemption applies across all classes.

    Lei 14.874/2024 — Brazilian Clinical Research Law

    Lei 14.874/2024, enacted in 2024, is the overarching federal law governing clinical research in Brazil. Articles 2 XXI and 2 XXXII define key terms including “clinical investigation” and “strictly academic study,” drawing the boundary between studies that are and are not subject to full regulatory oversight. Article 58 addresses the CEP/CONEP approval pathway as the operative approval requirement for studies that fall outside mandatory ANVISA pre-review. The definitions in Lei 14.874/2024 are the legal anchor for the academic/non-commercialization distinction used in RDC 837/2023 and reinforced in Protocol 2025289179.

    Decreto 12.651/2025 — Operative Since October 8, 2025

    Decreto 12.651/2025, which entered into force on October 8, 2025, provides the executive regulatory framework implementing Lei 14.874/2024. Article 9 of the Decreto is particularly relevant: Item II describes the conditions under which a study requires full regulatory submission, while Item III describes the conditions — including the academic and non-commercialization criteria — under which a study may proceed under Ethics Committee review alone. The Decreto’s operative date (October 8, 2025) precedes the issuance of Protocol 2025289179 (December 9, 2025), confirming that the ANVISA clarification was issued in the context of a legal framework already in effect.

    ANVISA Protocol 2025289179 — GGTPS Written Response, December 9, 2025

    The written response from the General Office of Technology Products for Health (GGTPS — Gerência Geral de Tecnologia de Produtos para a Saúde), signed by ANVISA officer Rafaela de Lima Avelino, is the direct primary source confirming that the academic, non-commercialization exemption applies to all device risk classes. It is not a guidance document or a policy statement — it is a written regulatory position issued in response to a specific factual query. Its evidentiary weight for sponsors planning a CEP-only pathway is therefore high.

    Real-world precedent

    The academic/non-commercialization device study pathway in Brazil has not been purely theoretical in the period following the legislative and regulatory changes of 2024 and 2025. Recent Class III-equivalent device first-in-human studies have been conducted at leading academic medical centers in São Paulo under Ethics Committee approval, with no ANVISA dossier filed and no ANVISA enforcement action. These studies were sponsor-supported in their funding structure, with the protocols characterized as academic in purpose, and were designed to generate the clinical data required to support U.S. FDA IDE filings.

    bioaccess® does not disclose the identities of the sponsors, sites, or devices involved in its programs. What can be stated is that the pattern has emerged consistently: a MedTech sponsor with a novel device, a first-in-human objective, and no near-term Brazilian commercialization intent has been able to activate a study in Brazil without opening an ANVISA regulatory dossier, provided that the protocol was appropriately structured and that the importation authorization for the investigational device was obtained in parallel.

    Practitioners’ guides published in 2025 and 2026 acknowledge the academic study pathway as an established mechanism; specific commentary varies, and sponsors should rely primarily on the four primary sources cited above rather than on secondary guides. Sponsors who have engaged Brazilian regulatory counsel in advance of protocol finalization have generally navigated the CEP/CONEP process cleanly.

    Important caveats every sponsor should know

    Protocol 2025289179 is an important clarification, but it does not eliminate regulatory complexity. Sponsors considering the CEP-only pathway should understand four caveats before contracting.

    Caveat 1: The protocol must explicitly and unambiguously state no Brazilian registration intent.

    The academic/non-commercialization exemption is conditioned on the study’s purpose as documented. A protocol that is silent on Brazilian commercialization intent, or that includes ambiguous language such as references to potential future market development in Brazil, may not meet the threshold. Sponsors should work with Brazilian regulatory counsel to ensure the protocol language is explicit: the study is conducted for academic or scientific purposes, and the sponsor does not intend to use the data to support a Brazilian ANVISA registration application.

    Caveat 2: ANVISA importation clearance (RDC 172/2017) for the investigational device remains required.

    Obtaining CEP/CONEP approval without an ANVISA regulatory dossier does not exempt the sponsor from obtaining ANVISA importation clearance under RDC 172/2017 for the unregistered investigational device into Brazil. Importation authorization is a separate administrative process that runs in parallel with site activation. It is mechanically distinct from regulatory review of the study itself, and it must be completed before the device can physically enter Brazil for use in the study. Sponsors who plan for CEP/CONEP approval but fail to account for importation authorization timelines will encounter delays at the device logistics stage. bioaccess® manages this process as part of its standard activation workflow. See the dedicated importation section below for the full process.

    Caveat 3: CEP-only data cannot later be used for Brazilian registration. This is categorical, not a soft preference.

    This is the single most consequential limitation in Protocol 2025289179, and it is stated in unambiguous terms in ANVISA’s December 9, 2025 response. The verbatim Portuguese:

    “Entretanto, alertamos que os dados obtidos em investigações clínicas realizadas no Brasil com dispositivos médicos sem anuência prevista na RDC nº 837/2023, não poderão ser utilizados para comprovação de desempenho, eficácia e segurança junto à Anvisa para fins de registro em petições futuras.”

    Translation: “However, we warn that data obtained in clinical investigations carried out in Brazil with medical devices without the consent provided for in RDC No. 837/2023 cannot be used to prove performance, efficacy, and safety to Anvisa for registration purposes in future petitions.”

    A sponsor who later decides to commercialize the device in Brazil must run a separate, ANVISA-supervised registration study — the CEP-only EFS data is regulatorily inert for Brazilian registration purposes. This is not a position bioaccess® can negotiate or work around. It is the explicit text of ANVISA’s written confirmation, and it must be reflected in the sponsor’s regulatory strategy from day one. Sponsors who have any plausible path to Brazilian commercialization in their long-range plan should obtain a formal legal opinion on this point before choosing the CEP-only route.

    Caveat 4: Commercially-sponsored EFS studies warrant Brazilian legal opinion.

    The protocol-level distinction between an academic institution-led study and a commercially-sponsored Early Feasibility Study (EFS) involves nuances that are not fully resolved by RDC 837/2023 or Protocol 2025289179 alone. A commercially-structured EFS where the sponsor has meaningful involvement in study design, execution oversight, and data ownership introduces questions about whether the study meets the academic characterization under Lei 14.874/2024. This warrants a formal opinion from qualified Brazilian legal and regulatory counsel before the sponsor contracts for study execution.

    bioaccess® can refer sponsors to experienced Brazilian regulatory counsel and can coordinate the legal opinion process as part of trial planning. We do not substitute our operational expertise for legal advice, and we recommend that sponsors seeking certainty on these questions obtain a written legal opinion before committing to the CEP-only pathway.

    How the investigational device gets into Brazil — the importation layer ANVISA still controls

    ANVISA Protocol 2025289179 removes the requirement for pre-study ANVISA review of the clinical investigation itself. It does not remove ANVISA’s authority over what enters Brazil. Any foreign investigational medical device — regardless of whether the underlying study is registrational or non-registrational — requires ANVISA importation clearance before it can clear Brazilian customs. This is not a scientific review of the study; it is a separate administrative process handled by a different ANVISA unit, and it must be properly set up before the first device unit ships.

    Two distinct ANVISA functions, two distinct ANVISA units

    The clinical-trial review function (which Protocol 2025289179 deemed dispensable for academic, non-commercialization studies) sits with GGTPS — the Gerência Geral de Tecnologia de Produtos para a Saúde. The importation clearance function sits with PAFPS — Posto de Anuência de Importação de Produtos para Saúde, ANVISA’s Port, Airport, and Border post operating at points of entry. The two units operate under different regulations and different timelines. A sponsor running a CEP-only EFS is exempt from GGTPS clinical review but is not exempt from PAFPS importation clearance.

    ANVISA’s own clinical-research FAQ (CPPRO/GGTPS, November 13, 2024) is explicit on this point: for device clinical research outside DICD scope, “o processo de importação de dispositivos médicos … para fins de investigação clínica deve ser realizado como importação de bens e produtos destinados à pesquisa científica ou tecnológica e à pesquisa envolvendo seres humanos, de acordo com as Resoluções RDC nº 172/2017 e RDC nº 613/2022 e suas atualizações” — meaning the RDC 172/2017 research-importation pathway is the operative mechanism.

    Two importation pathways — and which one applies to non-registrational studies

    The applicable importation route is determined by the study’s purpose, and the two pathways are structurally distinct and non-overlapping.

    For studies that are intended to support Brazilian ANVISA registration (DICD-filed studies), the operative petition code is 90351 (“Anuência de Importação de produtos para saúde sob Pesquisa Clínica”), with regulatory basis in RDC 548/2021 and Chapters XXVI and XXVII of the Annex to RDC 81/2008. Under this pathway, the importer must hold an Autorização de Funcionamento (AFE) under RDC 16/2014, must submit a Termo de Responsabilidade per Chapter XXVII of the RDC 81/2008 Annex, and the import is anchored to an ANVISA-issued CE, CEE, or “Documento para Importação de Produto(s) sob Investigação” tied to the DICD authorization.

    For non-registrational EFS studies — the scenario addressed throughout this post — the applicable framework is RDC 172/2017 (as amended by RDC 613/2022), specifically Article 5, which governs importation of products under sanitary surveillance intended for “pesquisa envolvendo seres humanos sem fins de registro” (human research without registration purpose). RDC 172/2017 Article 1 item XIII defines this category in language that maps exactly to Lei 14.874/2024 Article 2 item XXXII. Article 7 of RDC 172/2017 confirms the structural separation: the research-importation provisions explicitly do not apply to registration-purpose studies, which use the DICD pathway. This produces a clean, binary, non-overlapping framework.

    Under the RDC 172/2017 pathway:
    – No AFE is required. Importers operating under RDC 172/2017 are explicitly exempt from the Autorização de Funcionamento requirement, per the 2024 ANVISA GCPAF workshop guidance and RDC 860/2024.
    – No CE, CEE, or “Documento para Importação” is issued. Those documents are DICD-linked and do not exist in the non-registration pathway.
    – The importation petition is filed via SISCOMEX with an LPCO (Licença, Permissão, Certificado ou Outro Documento) submission to PAFPS.
    – The specific 90xxx PAFPS petition code applicable to non-registrational device imports is not enumerated on ANVISA’s published April 2024 codes page — it is confirmed with the customs broker at filing time based on the device type and study context. Sponsors should engage a Brazilian customs broker with current PAFPS experience to confirm the operative code for the specific shipment. bioaccess® coordinates this through its Brazilian importation partner.

    Importer of record — who can legally bring the device into Brazil

    Under RDC 172/2017 Article 5 §4, importation by a natural person (pessoa física) of products subject to ANVISA regularization that have not yet been regularized is explicitly prohibited. The importer of record must be a Brazilian legal entity (pessoa jurídica). The foreign sponsor, unless it has a registered Brazilian subsidiary qualifying as a research importer, cannot act as importer directly.

    When the foreign sponsor is not the importer of record, the Brazilian importing entity acts under a delegation arrangement, and a Termo de Responsabilidade per Annex I of RDC 172/2017 must be signed by the Brazilian importer. RDC 613/2022 strengthened this Termo de Responsabilidade to include declaration of the inventory of all prior importations for the same research project, allowing PAFPS to verify quantities against the CEP-approved protocol.

    Article 6 of RDC 172/2017 establishes that importation by a legal entity for human research with unregularized products must be mandatorily preceded by CEP and, where applicable, CONEP approval of the study. This means the importation petition is filed after ethics committee clearance — not in advance of it. The Termo de Responsabilidade declares the CEP/CONEP approval status.

    Practical timeline — meaningfully faster than the registrational pathway

    The PAFPS authorization under RDC 172/2017 Article 5 §1 is required to be completed within 48 hours after the arrival of the goods in national territory, provided the SISCOMEX LI has been pre-registered and all required documentation is in order. For institutions credentialed by CNPq (the Brazilian National Council for Scientific and Technological Development) under a tax-exemption regime with the Federal Revenue Service, Article 5 §2 provides for automatic deferral of the SISCOMEX import license — meaning PAFPS clearance is granted without manual ANVISA review of the petition.

    This is materially faster than the DICD-linked registrational importation pathway, which involves ANVISA technical review and typically runs in the multi-week range. For a sponsor running a CEP-only EFS through a CNPq-credentialed institution or a Brazilian research importer with appropriate credentialing, the device can be on-site within days of arrival in Brazil, not weeks.

    Tax and customs treatment — meaningful benefits for credentialed importers

    Investigational devices entering Brazil under the RDC 172/2017 research-importation pathway qualify for a tax exemption stack that is not available under standard commercial importation:

    • Lei 8.010/1990 provides exemption from Imposto de Importação (II), Imposto sobre Produtos Industrializados (IPI), and Adicional ao Frete para Renovação da Marinha Mercante (AFRMM) for goods imported by CNPq-credentialed scientific and technological institutions or by entities importing through them.
    • Convênio ICMS 104/89 provides exemption from Imposto sobre Circulação de Mercadorias e Serviços (ICMS) at the state level, on the same terms.

    In practice, this means a CNPq-credentialed Brazilian research importer pays minimal tax and customs duty on the inbound investigational device shipment. For a foreign sponsor that has not yet established Brazilian research-importer credentialing, working with an importer of record that holds CNPq credentialing is the most direct route to capture these benefits. bioaccess® coordinates this credentialing pathway through its Brazilian importation partner.

    Documentation checklist for the RDC 172/2017 importation petition

    The core documentation required to support the PAFPS importation petition under RDC 172/2017 includes:

    • The CEP-approved (and, where applicable, CONEP-approved) study protocol, with the academic, non-commercialization purpose statement clearly documented
    • Termo de Responsabilidade signed by the Brazilian legal-entity importer of record, per Annex I of RDC 172/2017 (as updated by RDC 613/2022 to include inventory of prior importations)
    • Commercial invoice and bill of lading from the foreign supplier
    • Delegation document from the foreign sponsor authorizing the Brazilian importer, when the sponsor and importer are distinct legal entities
    • Secondary and external packaging labels for the investigational device showing the CEP-approved clinical protocol number, storage conditions (temperature, humidity, light exposure requirements), and lot or serial number sufficient for traceability throughout the study
    • SISCOMEX LI registration with the PAFPS-appropriate petition code, confirmed with the customs broker at filing time

    Packaging label compliance is frequently a cause of delay at the customs clearance stage. Labels must be prepared in Portuguese or in a bilingual format acceptable to ANVISA, and they must include all required fields before the shipment is tendered to the carrier.

    bioaccess® manages the full importation authorization workflow as part of its CRO scope, coordinating between the foreign sponsor, the Brazilian importer of record (with CNPq credentialing where appropriate to access the Lei 8.010/1990 and Convênio ICMS 104/89 tax exemptions), and PAFPS at the point of entry. For sponsors unfamiliar with the Brazilian research-importation framework, this is the component of study activation where the right local partner pays for itself in both timeline and total landed cost.

    What this means for first-in-human programs

    For MedTech sponsors evaluating where to run their first-in-human study, Protocol 2025289179 and the surrounding legal framework make Brazil more competitive than the regulatory overhead of the U.S. or EU pathway for academic device studies.

    A properly structured CEP-only study in Brazil activates through the ethics committee system. CEP/CONEP review timelines, while variable, have been compressing since the introduction of Lei 14.874/2024’s 90-business-day ANVISA review limit (which now creates a predictable ceiling on full-regulatory-pathway timelines as well). For academic studies, the absence of an ANVISA pre-submission requirement means the critical path is defined by CEP/CONEP, site contracting, and device importation — all of which bioaccess® manages as an integrated workflow.

    Brazil offers a combination of clinical infrastructure, patient population scale, experienced investigators at academic medical centers, and now a clarified regulatory pathway that reduces the administrative burden for academic device studies. For a MedTech startup running its first FIH study and targeting an FDA IDE or CE Mark — not a Brazilian commercial registration — the cost and timeline differential relative to conducting the same study in the U.S. or a Western European country is meaningful.

    bioaccess® was purpose-built for exactly this scenario: startups that need a high-quality, cost-efficient first-in-human study that generates FDA-credible data, with a CRO partner that understands both the operational and regulatory landscape in Latin America. We back our programs with a 12-month timeline guarantee because we have designed our workflows — including ANVISA importation authorization, CEP/CONEP management, and site activation — to run on a defined schedule.

    If you are evaluating Brazil for a device first-in-human study and want to understand whether the CEP-only pathway applies to your specific protocol and device class, the right next step is a direct conversation. Schedule a free consultation at bioaccessla.com/book-a-meeting.

    Frequently asked questions

    bioaccess® is a contract research organization (CRO) specializing in first-in-human clinical trials and market access for medical devices and biopharma in Latin America. This post is intended for general informational and educational purposes and does not constitute legal, regulatory, or medical advice. Sponsors should obtain qualified legal and regulatory counsel for their specific programs.

  • $8 Billion Of Pharma Capital Just Pointed At Argentina. What Medtech Founders Should Take From The May 29 CAEME Announcement.

    On May 29, 2026, the Cámara Argentina de Especialidades Medicinales (CAEME) announced jointly with President Javier Milei a six-year clinical research investment commitment from seven multinational pharmaceutical companies: Pfizer, Merck, Roche, Novartis, BMS, GSK, and Sanofi. The total commitment is USD 8 billion through 2032. On the same week, ANMAT’s Disposición 2978/2026, which cut import tariffs on medicines and medical devices by 50 to 70 percent, came into operative effect on June 1.

    For a Latin American clinical research operator that has spent 16 years arguing the case to MedTech and biotech founders, the May 29 to June 1 sequence is the strongest sovereign-level signal a Latin American country has produced for clinical research in the past decade. The data and the policy arrived in the same week. The Big Pharma capital and the regulator’s tariff cut arrived in the same week. The case Argentina has been building since Disposición 7516/25 first came into force in 2025 is now publicly endorsed by both seven multinational CEO offices and the federal executive.

    The interesting question is not whether founders should use Argentina for first-in-human (FIH) work. The interesting question is what happens to the Argentine clinical research ecosystem when USD 8 billion of pharma capital flows into a site base that, in 2026, has only 80 to 120 actively credentialed Phase 1/2 sites. This post unpacks the saturation thesis and what early-stage MedTech founders should be doing about it in 2026.

    The Site Saturation Math

    The CAEME pledge of USD 8 billion over 2026 to 2032 implies an average commitment of approximately USD 1.33 billion per year. At industry-average sponsored Phase 1 through 3 trial costs of USD 1 to 3 million per site per year for clinical operations and site fees, the pledge fully funds roughly 430 to 1,330 new trial-site-years annually if disbursed at the announced pace.

    Argentine clinical research currently runs at roughly 290 ANMAT-authorized trials per year (2025 throughput), with 1,188 active studies under ANMAT supervision and approximately 80 to 120 actively credentialed Phase 1/2 sites across all therapeutic areas. The pledge contemplates a 2.5x step-up in trial inflows against approximately the same site base.

    The implication is straightforward. By 2027, Argentine Phase 1/2 site capacity becomes the binding constraint on the system. Regulator throughput, which is already operative at 62 calendar days under Disposición 7516/25, is no longer the rate-limiting step. Site availability is. And site availability at top investigators compresses asymmetrically. A senior PI running three trials in 2026 does not move to six trials in 2027. A senior PI running three trials moves to four trials, while the marginal Phase 1/2 site backlog elongates by 6 to 12 months for the founders arriving last.

    Founders who lock in Argentine site relationships in 2026 are locking in the top quartile of investigators. Founders who arrive in 2027 are competing for what is left after Pfizer, Novartis, and the other CAEME signatories have claimed the senior beds.

    Why the Argentine Government Did This Now

    Three forces converged in 2026 that made the May 29 to June 1 sequence possible. First, the Milei administration’s broader productivity and quality agenda, codified in the proposed PCT (Productividad, Calidad y Transparencia) bill, created the legislative context for industry investment commitments. Second, ANMAT’s operational reform sequence, beginning with Disposición 7516/25 (62-day pathway, parallel ethics plus agency review, ICH E6(R3) alignment), reached a level of regulator credibility that multinationals could underwrite. Third, the comparative landscape moved against Argentina’s peer regulators. Colombia’s Ley 191 stalled in Comisión Séptima and is now effectively dead this term. Brazil’s ICH E6(R3) adoption remains on a slower trajectory than ANVISA’s 2024-2025 board sessions suggested. Mexico’s 30-day target announced at AMIIF on May 19 lacks DOF formalization. Argentina is the only major LATAM jurisdiction in 2026 with operative regulatory reform, operative tariff policy, and operative sovereign-level industry commitment in the same week.

    The PCT bill is the only caveat that matters. The CAEME pledge is contingent on PCT passage. As of June 1, the bill remains stalled. Founders evaluating Argentine sites should treat the regulatory and tariff case as the base case and the CAEME pledge as additive upside. Disposición 7516/25 and Disposición 2978/2026 are in force regardless.

    How to Sequence Argentina in 2026

    The country sequencing decision a MedTech founder makes in 2026 is structurally different than the same decision in 2024. Two years ago, the case for Argentine FIH rested on cost (USD 15,000 to 35,000 per patient versus USD 40,000 to 75,000 in the U.S. and Europe) and regulator throughput (62 days under 7516/25 versus 120 to 180 days under FDA EFS). Both arguments still apply, and the Disposición 2978/2026 tariff cut now removes a 4 to 8 percent additional cost layer on imported devices and study drugs.

    What is new in 2026 is the time pressure. The CAEME pledge does not change the operational case. It changes the urgency of the operational case. A founder who has been considering Argentine site selection for the past six months and has not yet executed is, beginning June 1, 2026, on the wrong side of a closing window. By Q4 2026, the same site relationships will be visibly competitive. By Q2 2027, the top-quartile PI list will be substantively claimed.

    For structural heart and cardiovascular device programs, the recommended sequence is Argentine site selection initiated by Q3 2026, ANMAT protocol filing by Q4 2026, first patient enrolled in Q1 2027. This sequence preserves access to the InCor São Paulo, Hospital Italiano Buenos Aires, and Fundación Cardiovascular Bogotá tier of cardiovascular research centers, with the Argentine arm operating in parallel with a U.S. EFS submission.

    For neuromodulation programs, the recommended sequence compresses further. Site selection at seed close (or post-Series A), ANMAT protocol filing within 90 days of site lock-in. The neuromodulation patient base in Argentina is concentrated at fewer specialized institutions than cardiovascular work, and the saturation pressure on neuromodulation-credentialed PIs is therefore more acute. Founders who have not selected Argentine neuromodulation sites by end of 2026 will likely face 6 to 9 month delays in 2027.

    For radiopharmaceutical and theranostics programs, the operational sequence is different in kind. Site selection has to be scoped before ANY other operational step because of isotope logistics, central pharmacy capacity, and credentialed nuclear medicine institutions. Radiopharma founders who wait until post-acceleration or post-Series A to scope LATAM partners have already added 6 to 9 months to their pivotal timeline. The Argentine radiopharma site base is even more concentrated than the neuromodulation base, and the CAEME pledge is highly likely to direct radiopharma-adjacent investment into the same handful of credentialed institutions.

    What This Means for the Colombia Case

    For bioaccess® and for any founder using a LATAM CRO with Colombian site depth, the May 29 to June 1 sequence forces an honest reassessment. Colombia in 2026 holds the following: established U.S.-trained PI density at specific institutions (Fundación Cardioinfantil, Fundación Valle del Lili, Universidad Javeriana), strong therapeutic-area depth in cardiovascular and oncology, INVIMA throughput at roughly 90 to 120 days. Colombia does not hold: operative sovereign-level investment commitment, modern ICH E6(R3) framework alignment (Resolución 8430/1993 remains the operative framework), or a recent tariff reduction comparable to Disposición 2978/2026.

    The Colombia case for 2026 is no longer “cheaper and faster.” The Colombia case is “specific therapeutic-area depth, U.S.-trained PI networks, and complementarity to an Argentine arm.” For founders running cardiovascular or oncology programs requiring U.S. data acceptance under FDA IDE pathways, the Colombian PI base remains uniquely qualified. For founders running neuromodulation or radiopharmaceutical programs at the FIH stage, the Argentine arm is now the primary recommendation, with Colombian sites operating as the complementary geography rather than the primary geography.

    This is a more nuanced positioning than the one bioaccess® and other LATAM CROs have historically used. It is also the positioning that will hold up over the next 12 to 18 months as the Argentine site saturation pressure builds.

    What Founders Should Do Before End of Q3 2026

    For MedTech, biotech, and radiopharma founders who have not yet scoped their LATAM site portfolio, the practical sequence over the next 90 days looks like:

    First, identify whether the program’s FIH country sequence is Argentina-primary, Argentina-secondary, or Argentina-complementary based on therapeutic area, regulatory pathway, and capital constraints. For structural heart and cardiac ablation, Argentina-primary or Argentina-secondary makes sense. For neuromodulation, Argentina-primary. For radiopharma, Argentina-primary with explicit isotope logistics scoping. For oncology devices with U.S. IDE pathway requirements, Argentina-complementary alongside Colombia or Brazil.

    Second, scope site availability at the institutions most likely to be impacted by the CAEME pledge. The largest pharma signatories (Pfizer, Roche, Novartis) historically work with a specific set of Argentine investigators in cardiology, oncology, and metabolism. Site availability at those investigators will compress first.

    Third, file ANMAT protocols on the Disposición 7516/25 parallel-review pathway. The 62-day timeline allows a 2026 Q3 site selection to produce first-patient-in by year-end. Delays beyond Q3 begin pushing first-patient-in into Q2 2027, by which point the competitive pressure on senior PIs will be visible in enrollment delays.

    Fourth, consider the Disposición 2978/2026 tariff cut as a planning input. The 50 to 70 percent reduction on imported devices and study drugs is most material for early-stage MedTech programs that import 80 to 100 percent of investigational supply. Plan device manufacturing and shipment timing to maximize the tariff savings.

    The Bottom Line

    Argentina did not become a clinical research hub on May 29, 2026. Argentina has been a clinical research hub for 30 years. What happened on May 29 to June 1, 2026, is that the federal executive, the regulator, and seven multinational pharma CEOs publicly aligned on the same operational thesis in the same week. That alignment compresses the founder decision window from years to quarters.

    For early-stage MedTech, biotech, and radiopharma founders evaluating LATAM FIH strategy, the operational reality is that the next 12 to 18 months are a sponsor-favorable market with multiple jurisdictions actively recruiting trial volume. Sponsors who position now benefit from regulator attention, expedited review windows, and access to the senior PI base. Sponsors who delay lose that window.

    The most expensive FIH decision a founder makes is not the per-patient cost of a single study. It is the calendar cost of choosing the wrong country sequence for their specific program. Argentina’s May 29 to June 1 sequence makes the calendar argument harder to ignore.

    If you are evaluating a 2026 LATAM FIH country sequencing decision and want a tailored proposal that incorporates the new ANMAT regulatory and tariff environment alongside Colombian and Brazilian complementary site options, the team at bioaccess® can produce a country-level model within two weeks. We have run FIH trials across Argentina, Colombia, Brazil, and Mexico since 2010, and our U.S. EFS plus LATAM FIH practice is the only one in Latin America structured to deliver both pathways under a single operational team.

    Citations:

  • Argentina Just Cut Clinical Trial Import Costs By 50 70%. Here’s What 290 Authorized Trials In 2025 Tell Founders.

    On May 19, 2026, Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) published Disposición 2978/2026, cutting import tariffs on medicines and medical devices by 50 to 70 percent, effective June 1, 2026. The preamble of the instrument states the policy goal explicitly: to attract clinical trial investment to Argentina. The next day, the Argentine government released throughput data that explained why the policy was built: 290 clinical trials authorized in 2025, a 12 percent year-over-year increase, with 114 already authorized in the first quarter of 2026 and 1,188 active studies under ANMAT supervision. Argentina is now formally branding itself an “internationally competitive clinical research hub.”

    For a Latin American clinical research operator who has spent 16 years arguing the speed-and-cost case to MedTech and biopharma founders, the May 19-20 sequence is the most unusual validation event the regulatory landscape has produced this decade. Most LATAM clinical research positioning is CRO marketing. Argentina’s came from the regulator itself, in the preamble of a binding instrument, on government letterhead, with throughput numbers attached. That is not the same kind of evidence as a competitive pitch deck.

    For founders running a 10-patient first-in-human (FIH) device study, the math now stacks in a way that materially changes the country sequencing decision. This post unpacks what changed, what stayed the same, and how founders pursuing a U.S. Early Feasibility Studies (EFS) plus out-of-U.S. (OUS) FIH strategy should think about Argentina in 2026.

    What Changed on May 19, 2026

    Disposición 2978/2026 is the binding instrument. The tariff reduction applies across the import basket relevant to clinical research operations, including investigational drugs, medical devices in trial-supply quantities, reference standards, and disposable consumables tied to study protocols. The pre-existing effective duty rate for imported medical devices in Argentina ranged from 12 to 18 percent before May 19. Under the new schedule, that effective rate compresses to roughly 6 to 12 percent for trial-supply imports, with category-specific reductions ranging from 50 to 70 percent depending on the harmonized system classification.

    On its own, the tariff cut is meaningful. It is more meaningful in combination with the operational baseline Argentina already had in place. Disposición 7516/2025, which came into force in 2025 and is fully aligned with ICH E6(R3), caps clinical trial protocol authorization at 62 calendar days (45 working days maximum). That includes parallel ethics committee review and ANMAT agency review, not sequential review. For comparison, the U.S. EFS pathway typically runs 120 to 180 days from IDE submission to first patient enrolled. Argentina’s ANMAT pathway is 60 to 120 days faster, depending on the comparison case.

    The April 24, 2026 importación simplification further compresses pre-first-patient timelines by removing roughly 14 to 21 days of customs and import-classification delay that previously sat between protocol approval and the actual arrival of study material at site. The June 1, 2026 tariff reduction now removes the cost penalty that previously sat alongside that delay.

    The Throughput Number Most Founders Miss

    The 290-trials-in-2025 figure deserves more attention than it has received. Of those 290 authorizations, the regulator-reported mix is approximately 70 percent biopharma and 30 percent medical device or combination product. The Q1 2026 pace of 114 authorizations annualizes to roughly 456 trials per year, which would represent a 57 percent year-over-year acceleration if sustained. Even if the run rate moderates by half, Argentina’s 2026 throughput will exceed all prior years on record.

    For a founder evaluating site capacity risk, the 1,188 active studies under ANMAT supervision is the more strategic data point. Argentina has the patient-volume depth and the principal-investigator network density to absorb new sponsor demand without the recruitment friction that emerging-market sites with thinner trial histories often impose. A FIH MedTech sponsor running a 10-patient study at two Argentine sites can realistically expect first-patient-in within 90 days of protocol approval, and last-patient-in within 5 to 7 months of contract execution. Those numbers have been stable across the last 36 months of bioaccess® operational experience.

    The Cost Math, Refreshed

    Pre-May 19, 2026, the LATAM per-patient cost range for a FIH MedTech study sat at $15,000 to $35,000, compared to $40,000 to $75,000 in the U.S. and Europe. For a 10-patient FIH device study, that is a $250,000 to $400,000 absolute swing, sufficient on its own to fund roughly four months of clinical operations headcount or a complete adaptive design biostatistics package.

    The June 1 tariff reduction does not move the per-patient labor cost. It moves the device and drug-import cost component, which typically represents 8 to 15 percent of total study cost for a MedTech FIH trial relying on imported investigational devices. A 50 percent reduction on that line item produces a 4 to 8 percent reduction on total study cost, which compounds with the labor cost advantage Argentina already offered. On a $250,000 study, that is an additional $10,000 to $20,000 of effective savings. On a $1 million pivotal-stage Argentine arm of a multi-country trial, the effect grows proportionally.

    The strategic value is not the headline savings number. It is the regulatory clarity that the tariff cut produces. Sponsors evaluating Argentina now know that the regulator has formally committed to clinical research as a strategic policy priority. That changes how a CFO evaluates jurisdiction risk in the IND-enabling phase.

    The Database Anomaly and How to Work Around It

    One operational caveat is worth flagging directly. ANMAT’s public pharmacology database, which historically served as the citable reference for trial throughput and status, remains anchored at a September 30, 2025 data cutoff. As of the publication date of this post, that anomaly has persisted for four consecutive weekly review cycles. The most likely explanation is a backend migration tied to the broader Argentine government’s digital transformation initiative, but the database itself does not yet reflect Q4 2025 or any 2026 data.

    For sponsors building a regulatory dossier or a board pack that requires citable Argentine clinical research throughput data, the May 20, 2026 government statistics package, available through argentina.gob.ar communications channels, is now the more authoritative source than the database. For real-time individual study status, the RENIS (Registro Nacional de Investigaciones en Salud) registry, accessible through the SISA portal, remains operative and current. Disposición 7516/25, the 62-day pathway, the importación simplification, and Disposición 2978/2026 are all fully in force regardless of the database refresh status.

    How to Sequence Argentina in a U.S. EFS Plus OUS FIH Strategy

    The most common 2026 founder question is whether to run U.S. EFS first, OUS FIH first, or both in parallel. The May 19-20 Argentina updates do not change the answer in every case, but they change it in enough cases that the question is worth re-examining.

    For structural heart, neuromodulation, and radiopharmaceutical or theranostic FIH programs, where the U.S. EFS pathway involves an IDE submission with 120 to 180 day review timelines, the parallel Argentina arm is now substantially more attractive. The argument runs as follows: a sponsor who files the IDE with FDA in month one and simultaneously files the ANMAT protocol under Disposición 7516/25 will, in a typical case, have ANMAT approval and first-patient-in achieved before the FDA has finished its initial IDE review. That bridge data, if collected against an FDA-aligned endpoint set, materially strengthens the IDE review and accelerates the post-IDE clinical trial path.

    The bridge data approach assumes the sponsor designs the Argentine arm to match the FDA-expected endpoints from the outset. That is not a regulatory obligation in Argentina, but it is the operational discipline that converts a 62-day pathway into a strategic asset rather than a parallel cost center. ICH M11 CeSHarP, finalized by ICH on May 21, 2026, makes that endpoint-aligned protocol authoring substantially more efficient than it was a year ago.

    For absorbable implants, cardiac ablation, and oncology device FIH programs, the Argentina arm makes sense as the primary FIH site set, with the U.S. EFS following as a confirmatory phase rather than as the primary first-in-human exposure. The 2026 tariff reduction further tips the math in this direction for sponsors with capital constraints between Series A and Series B.

    What This Means for the Latin American Clinical Research Landscape

    Argentina’s May 19-20 sequence is the clearest example to date of a Latin American regulator choosing, in policy, to compete for clinical research investment. Brazil, Mexico, and Colombia have made similar moves in the past 24 months, but none have packaged a binding tariff reduction with a coordinated government statistics release in the same week. The combination is what makes the Argentine moment unusual.

    For Latin American CROs, the strategic implication is that the next 12 to 18 months will likely be a sponsor-favorable market, with multiple jurisdictions actively recruiting trial volume. Sponsors who position now will benefit from regulator attention, expedited review windows, and the willingness of agencies to engage with novel trial designs at the pre-submission stage. Sponsors who delay until the policy environment has fully stabilized will lose the strategic window.

    For bioaccess® and other LATAM operators, the implication is that the value proposition has moved beyond cost and speed into regulatory partnership. The conversation a founder needs to have with their CRO in 2026 is no longer about how fast the trial can run. It is about how the trial design, the country sequence, and the data architecture combine to compress the Innovation Runway, the operational window between a founder’s first FIH decision and the data package their next funding round requires.

    The Bottom Line for Founders

    Argentina has just made the clearest policy statement any Latin American clinical research regulator has produced in 2026. The 62-day pathway under Disposición 7516/25 is operative. The importación simplification is in force. The 50 to 70 percent tariff reduction on imported medicines and medical devices begins June 1. The throughput data confirms that the regulatory environment can absorb new sponsor demand at scale.

    For a MedTech, biotech, or radiopharma founder evaluating a 2026 FIH country sequencing decision, the Argentine arm now warrants serious consideration as the lead site or the parallel site for any program where the U.S. EFS pathway is the comparison baseline. The most expensive FIH decision a founder makes is not the per-patient cost of a single study. It is the calendar cost of choosing the wrong study to run first. Argentina’s May 19-20 sequence makes the calendar argument harder to ignore.

    If you are evaluating a 2026 FIH sequencing decision and want a country-level model that reflects the new Argentina policy environment, the team at bioaccess® can produce a tailored proposal within two weeks. We have run FIH trials across Argentina, Colombia, Brazil, and Mexico since 2010, and our U.S. EFS plus LATAM FIH practice is the only one in Latin America structured to deliver both pathways under a single operational team.

    Citations:

  • How To Read A CRO Capability Deck Like A Regulator (What The Marketing Doesn’t Say)






    How to Read a CRO Capability Deck Like a Regulator (What the Marketing Doesn’t Say)


    How to Read a CRO Capability Deck Like a Regulator (What the Marketing Doesn’t Say)

    Published May 11, 2026 | bioaccess®®

    You have $8 million in runway, a novel cardiac device, and a 10-patient first-in-human study to execute before your Series A conversation begins. A CRO has just sent you a 40-slide capability deck. The deck opens with a world map covered in pins. It lists therapeutic area expertise across oncology, cardiology, and neurology. It has a slide on “integrated Phase 1–4 capabilities” and another on “global QMS infrastructure.” It closes with a client testimonial from a pharma sponsor who ran a 200-site Phase 3 program.

    The deck is professionally produced and factually accurate. It is also almost entirely uninformative for your decision.

    Read it the way an FDA reviewer reads an IND submission: with a deliberate bias toward what is absent, not what is highlighted. A well-constructed IND foregrounds safety rationale, device description, and study design. A skilled reviewer immediately turns to what is omitted — the gaps in the risk analysis, the unstated assumptions in the device description, the absence of site-specific data. The omissions are where the decision lives.

    CRO capability decks follow the same logic in reverse. They are built to foreground strengths and suppress comparative weaknesses. For a founder making a CRO selection at the most consequential stage of clinical development — the first-in-human study — the standard capability deck is an exercise in strategic omission. This post identifies what to look for in the gaps.

    The “Risk-Reduction Partner” Tell

    In May 2026, ERGOMED ran a session at OCT Europe in Barcelona titled “Reframing the CRO: From Vendor to Risk-Reduction Partner.” The session is worth examining not as a critique of ERGOMED — it is a thoughtful positioning move for their target market — but as a diagnostic tool for understanding how full-service CROs think about their value proposition.

    “Risk-reduction partner” is Phase 3 enterprise vocabulary. In the context it is designed for, it is entirely appropriate. Sponsors running 200-site global oncology programs have a legitimate problem: execution risk at scale. The CRO’s job in that world is to absorb institutional complexity, manage deviation escalation across jurisdictions, and maintain data quality across a program that may run five years and involve hundreds of investigators. “Risk-reduction partner” accurately describes what those sponsors need.

    A MedTech founder with $8 million in runway and a 10-patient first-in-human study does not have that problem. The founder’s risk is not execution complexity. It is time-to-data and capital burn before the Series A window. Those are structurally different problems, and they require structurally different operational models.

    When a CRO’s conference positioning, capability deck language, and testimonial library are uniformly oriented toward large pharma sponsors managing late-phase complexity, that is a tell. The CRO has built its systems, its hiring model, its regulatory relationships, and its project management infrastructure for that world. When a FIH-focused MedTech founder engages that CRO, they are not in the wrong room — they are in a room designed for a different problem. The capability deck will not surface this distinction, because the CRO has no incentive to name it. The founder has to read it out of the omissions.

    The question is not whether a CRO is good at what it does. The question is whether what it does is what you need.

    What Gets Emphasized vs. What Gets Omitted

    CRO capability decks are designed by marketing and business development teams. They foreground what differentiates the firm in competitive presentations to late-phase sponsors, because that is the primary audience most CROs are selling to. When you receive one as a FIH MedTech founder, you are reading a document optimized for a different buyer.

    What is consistently foregrounded:

    • Integrated Phase 1–4 capability (breadth signals institutional scale)
    • Global site footprint (pin maps create an impression of reach)
    • Late-phase QMS infrastructure (relevant to sponsors managing multi-site Phase 3 programs)
    • Therapeutic area expertise in high-revenue categories (oncology, CNS, rare disease)
    • Client testimonials from pharma sponsors, typically Phase 2–3 programs

    What is systematically omitted:

    • Per-patient cost ranges at the FIH stage. Capability decks price by service line, not by patient. A 10-patient FIH study in the United States or EU runs approximately $40,000–$75,000 per patient at comparable Latin American sites, the same study costs $15,000–$35,000. That is a $250,000–$400,000 difference on a 10-patient program. No capability deck will surface this unprompted.
    • Jurisdiction-specific approval timelines. U.S. academic IRBs average 6.5 months for initial review of a novel device protocol. That number does not appear in any capability deck from a CRO built on U.S. site infrastructure, because it is not a competitive advantage for them. It should be the first number you ask for.
    • The percentage of active portfolio that is first-in-human. A CRO that is 90% concentrated in Phase 2–4 programs has built its project management systems, its site relationships, and its hiring model for that concentration. Ask for the actual number.

    Reading a capability deck as a regulator reads an IND means asking: what would a competent operator omit from this document if they wanted to avoid a comparison they would lose? Those omissions are where your due diligence should begin.

    The 6–12 Month IRB Problem

    The most expensive problem in U.S. first-in-human development is not device complexity, not protocol design, and not CRO selection. It is IRB latency, and almost no CRO capability deck addresses it directly.

    U.S. Institutional Review Board approval for a novel medical device at an academic medical center averages approximately 6.5 months for initial review. When protocol revision cycles are included — which is the norm, not the exception, for first-in-human device studies — full startup-to-approval timelines routinely exceed 12 months. The FDA CDRH Early Feasibility Study program documentation and MDIC’s 10-year EFS program analysis both identify study startup latency as the primary bottleneck in U.S. FIH device development — not regulatory approval, not site selection, but the ethics review cycle itself.

    At typical early-stage burn rates of $500,000–$1,000,000 per month, a 6-month IRB delay consumes $3–6 million in operating capital before a single patient is consented. For a founder with $8 million in runway targeting a 10-patient FIH study, that latency can be program-defining.

    Colombia’s INVIMA approves medical device clinical trial applications in approximately 30 days. Ethics committee approval in bioaccess®-managed studies in Colombia has been achieved in 15–18 days, with a typical portfolio range of 4–8 weeks. Argentina’s ANMAT operates under Disposición 7516/2025, which establishes a 62-working-day maximum review standard. These are not anomalies — they are the output of system design and site relationships built over 16 years of operating exclusively in first-in-human studies across 10 Latin American countries.

    The question every founder should ask every CRO before reviewing a budget proposal: “What is your documented median IRB or ethics committee approval time in your primary operating jurisdiction over the past 24 months?” If the answer is vague, that is informative. If the answer is specific and it runs past 90 days, that is more informative still.

    The First-in-Human Percentage Question

    The second question a founder should ask — and the one most CRO capability decks are built to obscure — is: what percentage of your active portfolio is Phase 1 or first-in-human?

    The three largest contract research organizations globally — ICON, Syneos, and Parexel — are concentrated in late-phase development. ICON’s 2024 Annual Report shows that the substantial majority of its revenue comes from Phase 2–4 programs; FIH studies represent a small fraction of total portfolio activity. The same is true across the large-CRO sector. This is not a criticism — it reflects where the revenue is. But it has direct operational consequences for a FIH-stage founder.

    A CRO with 5% of its active portfolio in first-in-human studies has built its project management infrastructure, its site activation processes, its deviation escalation protocols, and its regulatory file templates for the other 95%. When a FIH MedTech study enters that system, it is managed on infrastructure optimized for Phase 3 complexity: more oversight layers, more standardized QMS requirements, more administrative burden than a FIH study needs or benefits from.

    The capability deck will say “Phase 1–4 integrated capabilities.” It will not say that Phase 1 represents 4% of active studies, that the Phase 1 team shares project managers with Phase 3 programs, or that the ethics committee relationships in your target jurisdiction were last activated 18 months ago on a different therapeutic area.

    A CRO that has run first-in-human studies exclusively since inception has made the opposite set of tradeoffs. Every hire, every site relationship, every regulatory file system, and every approval timeline benchmark in that organization reflects a single operational context. That specialization compounds over time: 16 years of FIH-only operations across 10 countries produces a very different institutional knowledge base than 16 years of integrated Phase 1–4 operations in which FIH is one service line among many.

    Ask the question. Get the number.

    The Concurrent OUS FIH + U.S. EFS Structural Advantage

    The FDA’s Early Feasibility Study program was designed specifically for novel medical devices at the earliest stages of clinical development. Under 21 CFR 812.28, EFS submissions receive expedited CDRH review, with approximately 70% approved within 30 days. The MDIC’s 10-year EFS assessment documents significant improvements in study startup timelines when founders use the EFS pathway rather than traditional IDE submission.

    The structural advantage that no large CRO’s capability deck will surface clearly: a specialized FIH CRO that can execute both OUS first-in-human enrollment (in Colombia, Argentina, or elsewhere in Latin America) and concurrent U.S. EFS enrollment under a single CRO relationship changes the founder’s decision calculus in a material way.

    Under a traditional model, a founder chooses: OUS FIH first, then U.S. enrollment — running two sequential programs, often with different CROs, rebuilding the regulatory relationship each time. The concurrent model eliminates that sequencing. OUS FIH data informs the U.S. EFS design in real time. The regulatory file management, the data quality systems, and the sponsor relationship are continuous rather than episodic.

    For a large full-service CRO, EFS is one line item in a catalog of hundreds. The EFS capability will appear in the capability deck. What will not appear is how many EFS studies the team has actually executed, what their median CDRH response time has been, or whether the team managing U.S. EFS operations has any continuity with the team that would manage OUS FIH enrollment. For a CRO that has built its OUS FIH operations over 16 years and added U.S. EFS as the logical extension of that same operational model, those answers are specific and documentable.

    Ask: “How many EFS submissions has your team submitted in the past 36 months, and what is your documented median CDRH response time?” Then ask the same question about your target OUS jurisdiction. The answers should be specific.

    Three Columns: What the Deck Says, What It Omits, What to Ask

    The following framework is designed to be used during CRO evaluation, before you engage in formal proposal negotiations. Apply it to every capability deck you receive.

    What the Deck Says What It Omits What to Ask to Fill the Gap
    Integrated Phase 1–4 capabilities Percentage of active portfolio that is Phase 1 or FIH “What percentage of your active studies are first-in-human or Phase 1, and what was that percentage 24 months ago?”
    Global site footprint Ethics committee / IRB approval timelines in target jurisdiction “What is your documented median ethics committee or IRB approval time in [your target country] over the past 24 months?”
    Service line pricing / budget proposal Per-patient cost isolated for FIH stage “Please provide a line-item budget with per-patient cost isolated from site management and overhead fees.”
    FDA acceptance language EFS submission volume and documented CDRH response times “How many EFS submissions has your team managed in the past 36 months, and what is your median CDRH response time?”
    Therapeutic area expertise Medical device FIH-specific experience vs. drug/biologic Phase 1 “What percentage of your Phase 1 portfolio is medical device studies under IDE or EFS, vs. drug or biologic IND?”

    The three-column exercise does not require adversarial questioning. A CRO with genuine FIH specialization will answer every question above with specific, documentable data. The absence of specific answers is itself the answer.

    Reading a CRO capability deck like a regulator means treating every foregrounded strength as a signal to ask what is structurally absent on the other side of that strength. The 40 slides are not the decision. The five questions above are the decision.

    Next Steps

    If you are evaluating CRO options for a first-in-human study and want a direct conversation about how bioaccess®® structures FIH programs in Latin America — including ethics committee timelines, per-patient cost benchmarks, and concurrent U.S. EFS execution — schedule a consultation at bioaccessla.com/book-a-meeting.

    To model the cost difference between U.S./EU and LATAM FIH execution for your specific protocol, use the bioaccess® clinical trial cost calculator.

    For the foundational framework this post extends — the five questions to ask before signing a CRO MSA — see Five Questions Every MedTech Founder Must Ask a CRO Before Signing the MSA.

    Sources


  • Five Questions Every Medtech Founder Must Ask A CRO Before Signing The MSA






    Five Questions Every MedTech Founder Must Ask a CRO Before Signing the MSA


    Five Questions Every MedTech Founder Must Ask a CRO Before Signing the MSA

    Published by bioaccess®® | May 2026

    The Most Expensive Vendor Decision You Will Make Before Your Series B

    The master services agreement you sign with a CRO at the first-in-human stage is not just a vendor contract. It is a commitment to a timeline, a data architecture, a regulatory strategy, and — in ways most founders do not fully price until they are inside the engagement — a bet on whether that organization has ever actually done this before.

    Most MedTech founders spend more time negotiating SaaS subscription pricing than interrogating the operational fitness of the CRO they are about to trust with their first human study. CROs are practiced at presenting capability decks that are both technically accurate and structurally misleading: yes, they have run first-in-human studies. The questions are how many, how recently, where, and with what kind of dedicated team.

    Getting this wrong is costly in ways that do not appear on the MSA. A generalist CRO that applies Phase 3 operational logic to a 10-patient FIH study produces delays and data packages that do not travel well to FDA. The five questions below are designed for use in an actual vendor conversation, written so that an organization built specifically for first-in-human work answers all five without hesitation and a generalist CRO with Phase 3 heritage struggles on at least three. The contrast is the diagnostic.

    Question 1: “What percentage of your active studies are first-in-human?”

    This question cuts through every capability deck. Most large CROs list “Phase 1-4” as an integrated capability — and that is technically accurate. ICON, Syneos Health, and Parexel all offer first-in-human services. What their materials do not disclose is the proportion of revenue, headcount, and operational attention that FIH commands relative to their Phase 2-4 and post-market portfolio. According to the ICON plc 2024 Annual Report, the company’s growth narrative is anchored in Phase 2-4 and functional service offerings. Syneos Health’s service model is similarly configured around integrated biopharmaceutical solutions at scale — not the 10-patient device feasibility study a seed-stage founder needs to execute.

    The operational implication: when FIH is a small fraction of a CRO’s active portfolio, the project managers on your study are people who primarily run Phase 3 logistics. They understand protocol compliance and site management at the multi-site scale. What they may not have is the judgment that comes from running dozens of first human exposures — the real-time risk calculus of dose escalation, the site selection nuances that matter when you have ten patients rather than three hundred, and the FDA communication posture that FIH-specific experience produces.

    The follow-up question matters equally: “Who on your team has personally run more than ten first-in-human studies from device selection through first patient in?” An organization that cannot surface a dedicated FIH unit with named individuals and verifiable track records has not built FIH as an operational discipline.

    Red flag: Any CRO that cannot give you a clean percentage of active studies that are first-in-human has not built FIH as an operational core. It is a line item in a service menu. A CRO for which FIH is the only practice answers this question with a number above 90 percent — because there is nothing else on the portfolio.

    Question 2: “What is your documented median time from IND/IDE submission to site initiation in your primary jurisdiction?”

    Timeline is not a soft preference. It is a capital efficiency variable. Every month between IND/IDE equivalent submission and first patient in is a month of runway consumed and a month of competitive exposure while your device sits in regulatory review.

    The documented benchmark for ethics committee approval in Latin American FIH programs — for organizations with established site relationships and a mature submission infrastructure — is 4 to 8 weeks. In Colombia, where the regulatory framework has been shaped by over a decade of FIH execution, approval instances as fast as 15 to 18 days have been recorded. This is the result of site-level relationships, submission formatting that ethics committees recognize, and a regulatory team with institutional familiarity with the FIH protocol type.

    The U.S. comparison is not subtle. The average IRB/EC cycle in the United States for a novel device IDE study runs 6 to 12 months from submission to site initiation when you account for FDA review, IRB submission, site contracting, and institutional compliance review. In the EU, a 6-month horizon from IDE equivalent to first patient in remains the conservative planning assumption most regulatory counsel will give you.

    Illustrative Ethics Approval Timeline Comparison
    Jurisdiction Documented Range Basis
    LATAM (Colombia, established sites) 4-8 weeks (fastest: 15-18 days) bioaccess® operational track record, 2010-present
    United States (IDE pathway) 6-12 months (submission to site initiation) FDA CDRH IDE review statistics
    EU (CTR pathway) 3-9 months (submission to site initiation) EMA Clinical Trials Regulation implementation data

    When you ask this question, you are asking for documented median performance, not a best case. An organization that cannot answer with data has not been measuring what matters.

    Question 3: “Have you produced a data package accepted by FDA from a non-U.S. trial in the past 36 months?”

    The most persistent misconception among U.S. device founders about outside the United States clinical data is that FDA will not accept it. This misconception is expensive, because it leads founders to dismiss LATAM and other OUS execution pathways as regulatory dead ends when the regulatory framework explicitly accommodates foreign clinical data.

    21 CFR 312.120 permits FDA acceptance of foreign clinical data when the trial was conducted in accordance with Good Clinical Practice and under a protocol FDA would consider adequate and well-controlled. 21 CFR 812.28 extends parallel provisions to device studies, explicitly addressing acceptance of data from foreign investigations in support of IDE and PMA submissions.

    A first-in-human study conducted in Colombia, Brazil, or Peru under a GCP-compliant protocol, with a data architecture designed to meet FDA standards, can generate the foundational data package that supports a U.S. IDE submission. The LATAM study is not a workaround. It is a legitimate regulatory pathway.

    Executing it correctly requires a CRO that has actually done it. “We could produce FDA-compatible data” is not the same as “we have produced FDA-accepted data from an OUS trial in the past three years.” Ask for the latter. Ask for the regulatory outcomes. Ask whether the data traveled to FDA and what the response was.

    A CRO that has never navigated 21 CFR 312.120 or 812.28 in practice — regardless of what their regulatory affairs team says in a capabilities presentation — is asking you to be their learning case at the stage where you cannot afford that tuition.

    Question 4: “What is your per-patient cost range for a 10-to-15 patient FIH study in your primary jurisdiction?”

    Per-patient cost for a FIH study is the single most compressed way to understand the financial architecture of a CRO engagement before you are inside one. Cost transparency at the proposal stage is not a courtesy — it is a due diligence requirement.

    The documented range for per-patient costs in Latin American clinical trial sites runs from approximately $15,000 to $35,000 per patient for a first-in-human medical device study. The equivalent range in the United States and European Union runs from $40,000 to $75,000 per patient for comparable FIH work. That differential — roughly 59 percent lower cost per patient in LATAM — reflects the structural economics of clinical site operations in markets where investigator compensation, institutional overhead, and support cost structures differ materially from U.S. and EU norms.

    On a 10-patient FIH study, the arithmetic is direct: U.S. execution at $40,000-$75,000 per patient produces a $400,000-$750,000 direct study cost. LATAM execution at $15,000-$35,000 per patient produces a $150,000-$350,000 direct study cost. The difference — $250,000 to $400,000 — is material capital at the seed or pre-Series A stage. It extends runway. It funds the follow-on safety cohort. It covers FDA pre-submission preparation. It is the difference between a founder who enters their Series A with FIH data and remaining runway, and one who spent it all to generate the same data in a U.S. site.

    A CRO that deflects to “it depends on the protocol” without offering a range for a standard FIH configuration has either not run enough FIH studies to have a stable cost model, or does not want you comparing numbers before you have signed.

    Question 5: “Can you execute an EFS submission and manage a concurrent OUS FIH study under a single operational team?”

    The FDA’s Early Feasibility Study program is one of the most underutilized regulatory tools available to U.S. MedTech founders. According to the FDA Early Feasibility Study Program, the EFS pathway is designed for early-stage devices where clinical data is needed to inform device design — precisely the stage at which a FIH study occurs. The MDIC 10-Year EFS Journey analysis documented that approximately 70 percent of EFS submissions receive FDA response within 30 days — a timeline that makes concurrent OUS and U.S. enrollment operationally feasible within the same funding window.

    The strategic logic of concurrent execution is about data architecture, not just speed. A LATAM FIH study generating safety and early efficacy signals in parallel with a U.S. EFS enrollment produces a richer, more FDA-defensible data package than either study would generate independently. The LATAM cohort contributes patient volume and diverse population data; the U.S. cohort generates data with direct site-level FDA familiarity. Together, they build an IDE submission or PMA dataset from a position of evidence rather than assumption.

    Executing this dual-track strategy requires a CRO that can manage both pathways under a coherent operational structure — not two separate vendor relationships requiring a founder as the integration layer. The question diagnoses whether a CRO has built the capacity to hold both regulatory tracks in a single team, or is offering LATAM execution on one hand and a referral to a U.S. partner on the other.

    The U.S. EFS pathway and a concurrent LATAM FIH study are not competing strategies. They are the same strategy, executed in parallel, by an organization that understands both regulatory environments as a single integrated operation.

    How to Use This Checklist

    These five questions are not adversarial. They are clarifying. A CRO that has built its operations around first-in-human work will not find them uncomfortable — they will find them efficient, because the answers surface quickly from an organization that lives in this space every day.

    Use the questions in the initial capabilities conversation, before you have a proposal on the table and a timeline pressure that makes switching feel costly. The moment to evaluate operational fit is before you have signed anything, not after you are inside a study running six months behind the timeline the capabilities deck implied.

    • What percentage of your active studies are first-in-human?
    • What is your documented median time from IND/IDE equivalent submission to site initiation?
    • Have you produced a data package accepted by FDA from a non-U.S. trial in the past 36 months?
    • What is your per-patient cost range for a 10-to-15 patient FIH study?
    • Can you execute an EFS submission and manage a concurrent OUS FIH study under a single operational team?

    If the answers satisfy all five questions, you are talking to a CRO that may be able to run your first human study competently. If they do not, you have learned something before the signature, not after.

    Ready to Run the Evaluation?

    bioaccess® works with MedTech founders at every stage of FIH preparation — from regulatory strategy through first patient in. If you want to talk through your specific program against these five criteria:

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