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.
