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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.

  • Brazil’s 90 Day Clinical Trial Clock: A Practical Activation Playbook For First-In-Human Studies

    Brazil’s 90-Day Clinical Trial Clock: A Practical Activation Playbook for First-in-Human Studies

    For MedTech founders and regulatory leaders, Brazil has quietly become one of the most “plannable” countries in Latin America for early-stage clinical activation. A core reason is Brazil’s recent legal and regulatory modernization, which introduced a defined review window and clearer guardrails for starting studies.

    This article translates the change into a sponsor-facing activation playbook: what the 90-business-day clock means, how it interacts with ethics approvals, and what you should build into your timeline to avoid rework. The goal is not to “rush” a trial—it’s to make your activation schedule predictable and audit-ready.

    1) What changed in Brazil (and why it matters for FIH planning)

    Brazil’s Law No. 14.874/2024 established a national system of ethics in research involving humans and introduced a defined 90-business-day review window for ANVISA’s assessment of clinical trial applications that support marketing authorization.

    In practical terms, this is a planning upgrade. Sponsors can build a realistic activation calendar, align manufacturing and logistics windows, and avoid “open-ended” waiting periods that often inflate costs in early-stage programs.

    Importantly, Brazil still requires both ethics approval and ANVISA approval before initiation. However, the rules allow parallel submission so you can run key workstreams concurrently rather than serially.

    2) The activation sequence: ethics, ANVISA, and parallelization

    For most sponsors, the fastest compliant path is a two-track plan:

    • Track A (Ethics): prepare site documents, informed consent, investigator materials, and submit to the local ethics committee process.
    • Track B (Regulatory): prepare the ANVISA dossier and submit in parallel, ensuring your package is consistent with what ethics committees will see.

    A common pitfall is treating ethics and regulatory packages as separate artifacts. Instead, use a single “source of truth” for protocol versioning, risk language, endpoints, and safety reporting workflows.

    3) Don’t miss the hidden gating item: the trial-specific dossier

    Brazil’s process includes a key practical requirement: ANVISA’s technical analysis of the primary petition may depend on the filing of a trial-specific dossier. That means your internal readiness must include not only the umbrella development dossier, but also at least one trial-specific submission with the minimum documentation set.

    Operational takeaway: build your activation plan around “dossier completeness” milestones, not just “submission sent.” Sponsors who plan only to the submission date often discover late-stage gaps in translations, investigational product documentation, or safety reporting alignment.

    4) What “decurso de prazo” means (and what it does NOT mean)

    Brazil’s reforms also created an important concept often summarized as decurso de prazo: if the health authority does not issue a decision within the legal timeline and the study has the required ethics approvals, clinical development can begin.

    For sponsors, this is best treated as a risk-managed backstop rather than a default strategy. Your activation plan should still assume you will operate with an explicit authorization outcome and complete documentation. Use the statutory timeline to reduce uncertainty—not to reduce diligence.

    5) A sponsor-ready 90-day activation checklist

    If you want to benefit from predictable timelines, your internal systems must be “startup-ready” before the clock runs out. Here is a checklist that consistently prevents avoidable delays:

    • Regulatory narrative consistency: protocol synopsis, device/drug description, intended use, and risk statements match across all documents.
    • Import and labeling readiness: confirm investigational supply chain steps, packaging needs, and local labeling conventions early.
    • Safety workflow: clear SAE reporting path, vendor responsibilities, and escalation coverage (including weekends/holidays).
    • Data integrity: eCRF, source templates, and monitoring plan support inspection readiness from Day 1.
    • Site enablement: training plan, delegation logs, and equipment calibration records are not afterthoughts.

    6) How to use Brazil strategically inside a Latin America multi-country plan

    Many early-stage sponsors run a multi-country Latin America strategy to balance speed, cost, and enrollment diversity. Brazil’s clearer timeline can play multiple roles:

    • Anchor country: you plan your “first patient in” forecast around a predictable activation window.
    • Evidence builder: you generate high-quality data to support later reimbursement or regulatory submissions elsewhere.
    • Operational benchmark: you standardize SOPs and monitoring routines that can be replicated across the region.

    The key is harmonization: standardize your core protocol and quality system while adapting country-level workflows (ethics requirements, import pathways, and contracting norms).

    FAQ

    Does Brazil still require ethics approval before starting a clinical trial?

    Yes. Sponsors should plan for both ethics and regulatory authorization and use parallel workstreams to compress time without compromising compliance.

    Is the 90-business-day period a guarantee that my trial will be approved?

    No. It is a defined review window that improves predictability; approval still depends on dossier completeness and meeting regulatory and ethical requirements.

    What is the biggest activation mistake sponsors make in Brazil?

    Underestimating the time to assemble a trial-specific dossier and align all documents (protocol, consent, IP description, safety reporting). “Submitted” does not equal “complete.”

    Bottom line: Brazil’s reform is a planning advantage. Sponsors who pair it with disciplined document control, parallel submission strategy, and site readiness can reduce activation uncertainty—one of the most expensive problems in early-stage trials.

  • Brazil’s 90 Day Clinical Trial Review Cap: What Medtech Sponsors Should Do Before Submitting

    Brazil’s 90-Day Clinical Trial Review Cap: What MedTech Sponsors Should Do Before Submitting

    Brazil has moved from being a “high-potential but unpredictable” country for early-stage MedTech studies to a jurisdiction with a defined statutory review clock. For sponsors, that shift is not just a speed story — it is a planning story. When review timelines become shorter and more predictable, the relative impact of preventable sponsor-side errors gets larger.

    This article is written for MedTech founders, clinical operations leaders, and regulatory directors who want to run first-in-human (FIH) or early feasibility work in Brazil without losing weeks to rework. We focus on what you can control before submission: dossier readiness, ethics strategy, local operational prerequisites, and vendor orchestration.

    Why a faster regulatory clock changes the sponsor playbook

    Short timelines compress decision-making. If you used to “fix it after ANVISA feedback,” you may no longer have that luxury — because site contracts, import permits, radiology workflows, and ethics committee coordination can become the rate-limiting steps. A faster clock also forces clearer internal governance: who owns the final protocol, the risk assessment, the device technical file, and the country-specific annexes?

    Practically, the sponsor question becomes: How do we arrive at Day 0 with no missing pieces? The goal is to avoid pauses caused by translation gaps, document format mismatches, incomplete investigator packages, or unaligned device documentation.

    Pre-submission checklist: what to lock down before Day 0

    • Protocol version control: Confirm the final protocol, synopsis, schedule of assessments, and statistical plan are aligned — and that the same versions appear in every submission component.
    • Risk classification and device description: Ensure the device description, intended use, instructions for use, and risk analysis are consistent across documents. Inconsistency is one of the most common sources of questions.
    • Investigator and site packages: Collect CVs, training evidence, GCP documentation, and site capabilities early. In Brazil, the operational readiness of sites can become as important as the regulatory dossier.
    • Translations and local formatting: Build time for Portuguese localization and formatting checks. A strong translation is not only linguistic — it must preserve clinical meaning and match annex references.
    • Informed consent strategy: Prepare consent language that is clear, compliant, and aligned to local norms. If your device includes software, connectivity, or data transfer, incorporate that into consent and data handling text.
    • Import and logistics planning: Map the path for device shipment, labeling, and storage. Even for non-radioactive devices, customs, temperature needs, and distribution responsibilities can derail timelines.

    Parallel ethics + regulatory review: how to operationalize it

    When a system allows parallel tracks, the bottleneck often shifts to coordination. Sponsors should treat ethics submission as a project with its own critical path, not as an administrative afterthought. Build a unified submission calendar and align on:

    • Sequence of internal approvals: Decide who signs off on ethics content and who owns final responses.
    • Site-by-site variance: Even with a national framework, each site can introduce operational nuance. Standardize as much as possible, but plan for local adjustments.
    • Response management: Pre-write response templates for common questions (risk/benefit, recruitment strategy, device safety, data management) so you can move quickly.

    For FIH and early-stage work, ethics committees will often focus on patient protection and feasibility: training, emergency procedures, follow-up, and the practical ability of the site to manage adverse events. Your dossier should show readiness, not just compliance.

    What MedTech sponsors often underestimate in Brazil

    Speed-friendly frameworks do not eliminate complexity; they amplify the cost of under-planning. The most common underestimates include:

    • Data and privacy workflows: If your study uses digital endpoints or remote monitoring, align data flows, storage, and access controls early.
    • Device accountability: Plan how devices will be tracked, stored, returned, and reconciled. Accountability gaps create audit risk and can slow activation.
    • Training: Documented training is not optional in early-stage device studies. Build training into your timeline and capture evidence systematically.
    • Vendor interdependencies: CRO, imaging core lab, shipping/logistics, and local regulatory support must operate from the same timeline assumptions and document set.

    FAQ

    1) Does a statutory review cap guarantee approval in 90 days?
    No. A cap can improve predictability, but the practical timeline still depends on dossier quality, completeness, and how quickly questions are resolved.

    2) Should we treat Brazil as a first-choice country for FIH studies?
    Brazil can be compelling when the patient population, investigator expertise, and activation path fit the product. Sponsors should evaluate Brazil alongside other Latin American jurisdictions based on feasibility, ethics speed, and operational readiness.

    3) What’s the biggest sponsor-side mistake?
    Submitting with misaligned documents (protocol vs. device description vs. risk file) and assuming issues can be fixed “during review.” In faster systems, that approach often costs more time, not less.

    Bottom line: If your goal is to capture the benefit of a faster review framework, your work starts well before Day 0. A sponsor-side checklist — executed early — is often the difference between a fast approval and a slow cycle of preventable questions.

  • Brazil’s 2025 Clinical Research Rulebook: What Early-Stage Sponsors Should Do Differently

    Brazil’s 2025 Clinical Research Rulebook: What Early-Stage Sponsors Should Do Differently

    Brazil continues to be one of the most important anchors for early-stage clinical development in Latin America, but the compliance baseline is moving. In 2026, Anvisa highlighted that Brazil’s clinical research environment has been updated through Law No. 14.874/2024 (ethical aspects of research with human beings) and the newer regulatory package RDC 945/2024 plus IN 338/2024 for clinical research supporting registration of medicines, which Anvisa notes took effect in early 2025 (Anvisa).

    For MedTech founders and regulatory directors planning first-in-human (FIH) or early pivotal work in the region, the strategic opportunity remains: access to experienced investigators, high-quality sites, and diverse patient populations. The operational requirement, however, is to design submissions, vendor oversight, and essential documentation so you can demonstrate control at any moment—especially as inspection programs mature.

    1) What changed in Brazil’s research governance—and why it matters for sponsors

    Anvisa’s 2025 activity reporting explicitly connects the new ethical law and the updated clinical research regulation to the agency’s current oversight approach (Anvisa). In parallel, Anvisa’s inspection metrics reporting emphasizes inspection readiness against GCP expectations (ICH E6 (R2) or updates) while referencing RDC 945/2024 and Law 14.874/2024 as part of the inspection framework (Anvisa).

    Practical takeaway: even when timelines are competitive, sponsors should assume that documentation quality, vendor governance, and data integrity controls will be evaluated more explicitly. This is good news for well-prepared early-stage teams: strong fundamentals can shorten back-and-forth with sites and reduce downstream remediation.

    2) A sponsor-ready timeline: how to think about “FIH speed” without compliance debt

    Internal execution experience across Latin American programs repeatedly shows that speed usually breaks down in predictable places: incomplete essential documents, misaligned responsibilities between sponsor and CRO, and late-stage changes to protocol and informed consent artifacts. Treat “speed” as a systems outcome rather than a hero effort.

    • Pre-submission (4–8 weeks): lock protocol operational feasibility, confirm investigational product/device logistics, and establish a document control plan.
    • Submission-ready package: create a single source of truth for protocol, IB/IFU (as applicable), safety reporting plan, and data handling plan.
    • Site activation: standardize training, delegation, and vendor onboarding so the first site is not a one-off build.

    Many startups underestimate that “time to first patient” is often constrained by operational readiness, not just authority review. Investing early in a repeatable activation model is one of the highest ROI moves you can make.

    3) Inspection readiness: build once, benefit for years

    Anvisa’s inspection metrics report notes its focus on inspections conducted in 2024 and 2025 and positions inspections as a tool to protect participants and data integrity (Anvisa). For early-stage sponsors, the implication is clear: build inspection readiness into your operating rhythm rather than treating it as a “phase 3 problem.”

    Start with five non-negotiables:

    • Essential document discipline: version control, signatures, and clear ownership.
    • Delegation and training: role-based training mapped to tasks; keep it auditable.
    • Deviation and CAPA workflow: define severity levels and timelines; trend issues.
    • Vendor oversight: documented qualification, KPIs, and periodic review for CROs, labs, and logistics partners.
    • Data integrity: audit trails, access controls, and reconciliation between source, eCRF, and safety database.

    4) How to operationalize this across Latin America (not just Brazil)

    Brazil is rarely the only country in a Latin America strategy. Use Brazil as the quality anchor and replicate the same operating system across additional countries. You can localize what must be localized (ethics committee formats, language, import processes), while keeping your core compliance artifacts stable.

    A useful mental model: create a regional master file (core documents, SOPs, training), plus country modules (local submissions, contracts, import permits), plus site modules (delegation, logs, training, monitoring).

    FAQ

    When did Brazil’s latest clinical research regulations take effect?
    Brazil’s updated framework referenced by Anvisa includes Law 14.874/2024 (in force since 29 Aug 2024) and RDC 945/2024 plus IN 338/2024 (effective 2 Jan 2025).

    Do these changes apply to medical devices too?
    The Anvisa updates cited relate to clinical research for registration of medicines and biologics; device sponsors should still align operational quality systems and inspection readiness to ICH GCP expectations and local ethics requirements.

    How should startups prepare for inspection readiness?
    Build inspection-ready documentation from day one: role-based training, version-controlled essential documents, delegation logs, deviation management, and vendor oversight that can be demonstrated quickly.

    Need help designing a Latin America FIH plan? bioaccess® supports sponsors with regional feasibility, activation, and execution strategies built for speed and inspection readiness.

  • First-In-Human In Brazil In 2026: A Practical Timeline For Sponsors

    First-in-Human in Brazil in 2026: A Practical Timeline for Sponsors

    Primary keyword: first-in-human trial Brazil timeline

    Brazil is increasingly on the shortlist for early-stage clinical development because sponsors can combine a large patient base with growing regulatory clarity. A recent policy analysis argued that Lei 14.874 de 2024 created the basis for a more predictable environment and, for the first time, establishes timelines and greater regulatory clarity for clinical studies.

    This article gives a practical, sponsor-side timeline for launching a first-in-human (FIH) study in Brazil in 2026—what to do first, what typically slows teams down, and how to sequence work so you do not lose weeks to preventable back-and-forth.

    1) Define the “Brazil-ready” FIH package (Weeks 0–2)

    Before any submission, align internal stakeholders on what “Brazil-ready” means. For most MedTech and biopharma sponsors, FIH readiness is not only a protocol question—it is also a documentation and site execution question.

    • Protocol and IB alignment: Ensure endpoints, safety monitoring, and dose-escalation logic are consistent with your global plan.
    • Country adaptations: Identify what must be localized or supplemented (consent language, site materials, labeling, and investigator documentation).
    • Feasibility assumptions: Confirm whether required imaging, lab, or procedural capabilities exist at target sites.

    Internal best practice: Create a single “FIH Brazil master checklist” with owners and due dates. Treat it as a deliverable, not an afterthought.

    2) Select sites for speed, not just prestige (Weeks 1–4)

    In FIH, startup speed is highly correlated with site readiness. Sponsors often choose sites based on reputation, then discover contracting and operational realities late.

    • Prioritize operational maturity: Look for sites with dedicated research staff, established ethics processes, and experience with sponsor audits.
    • Validate recruitment pathways: Treatment-naive populations can be an advantage, but referral networks still matter.
    • Assess import and handling constraints: If your study uses temperature-sensitive materials, confirm storage and chain-of-custody procedures early.

    3) Build a parallel workstream plan (Weeks 2–6)

    The most common timeline mistake is running tasks sequentially that can be executed in parallel. Even when formal review clocks improve, sequential execution can erase the benefit.

    To compress time, run these workstreams at the same time:

    • Regulatory dossier preparation (quality, safety documentation, and trial authorization package)
    • Ethics submission package (site-specific documents and consent)
    • Contracts and budgets (CTA, indemnities, payment schedules, and monitoring model)
    • Supply and logistics readiness (import planning, labeling, storage validation, and back-up scenarios)

    Even when legal reforms aim to improve predictability, sponsors still need coordinated execution across stakeholders to realize those gains.

    4) Anticipate “hidden” startup time: contracts, import, and training (Weeks 4–10)

    Even when review timelines are favorable, sponsors can lose time after approvals due to operational bottlenecks:

    • Contract negotiation cycles: Build buffer time for legal review, redlines, and institutional sign-off.
    • Import and release: If your investigational product or device must be imported, confirm lead times and documentation requirements early.
    • Site initiation and training: FIH trials require strict adherence to safety procedures; schedule training sessions while approvals are in progress.

    Practical tip: Maintain a “go-live readiness dashboard” that tracks contract status, shipment readiness, and training completion. This prevents surprises when the green light arrives.

    5) A sponsor-friendly 2026 FIH timeline (example)

    Every program is different, but a realistic planning template looks like this:

    • Weeks 0–2: Brazil-ready protocol package, checklist, and internal alignment
    • Weeks 1–4: Site selection, feasibility, and early budget/CTA drafts
    • Weeks 2–6: Parallel dossier + ethics package finalization
    • Weeks 4–10: Contracts, import planning, training, and vendor setup
    • Weeks 10–14: Final site activation steps and first-patient readiness

    If you are aiming for speed, measure time-to-ready as rigorously as you measure time-to-approval. In many FIH programs, the fastest sponsors are simply the ones that avoid rework.

    FAQ: First-in-human trial Brazil timeline

    • How long does it take to start a first-in-human trial in Brazil?
      Timelines vary by protocol complexity and site readiness, but sponsors should plan for parallel regulatory and ethics pathways, early document localization, and realistic contracting and import lead times.
    • What is the biggest cause of FIH delays in Brazil?
      In practice, delays often come from incomplete documentation, late site selection, and underestimated startup logistics (contracts, import permits, and investigational product readiness), not just the formal review clock.
    • Can Brazil FIH data support US or EU submissions?
      Yes, when the trial is designed to international GCP standards and endpoints align with your global regulatory strategy, Brazilian data can be part of a broader evidence package.

    Need help planning an FIH startup in Brazil or across Latin America? bioaccess® supports sponsors with country startup planning, site activation, and operational execution—without exposing confidential details publicly.