When ANVISA's Clock Runs Out
By Julio G. Martinez-Clark, CEO, bioaccess
On June 18, 2026, Brazil’s health regulator let its clinical trial deadline decide. Through Resolution RE No. 2,413, the Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s National Health Surveillance Agency, released a batch of pharmaceutical clinical trial petitions “por decurso de prazo” — by lapse of time — because its review deadline had expired without a decision. The resolution appeared in the Diário Oficial da União (DOU), Brazil’s Federal Official Gazette.1
Reading this as a drug story is a mistake: the release ran on a drug pathway, but the statute underneath is product-agnostic. How a Class III/IV sponsor should plan depends on whether a Brazilian study is registration-directed or a genuinely non-registration first-in-human (FIH) early feasibility study (EFS) or proof-of-concept investigation whose data is not intended for ANVISA market authorization.
What Resolution RE 2,413 Actually Did
Resolution RE 2,413 authorized the implementation, by lapse of time, of pharmaceutical petitions whose review window had run out. Its stated legal basis is Article 58 of Law No. 14,874/2024 and Article 52, Paragraph 2, of Collegiate Board Resolution (RDC) No. 945/2024 — “decurso de prazo,” meaning the clock ran out before a decision was made.1
Precision matters. Decurso de prazo is not a scientific approval, a favorable merits review, or a safe harbor: ANVISA did not endorse the science, it gave effect to the consequence of an expired review window.1
The resolution’s annex listed eight numbered entries, and at least one — entry 3 — bundled a linked Clinical Medicinal Product Development Dossier and a Specific Clinical Trial Dossier (Dossiê Específico de Ensaio Clínico, or DEEC), showing the deadline bites across a submission’s life cycle, not only at first filing.1
One Law, Two Operating Rules
Law 14,874/2024 is often called a “pharma statute,” but it is not. Article 2 defines a clinical trial as research in humans evaluating “a medical device, experimental medicinal product, or advanced therapy” — human-research law that names devices.2
Article 58 sets the headline guarantee: the health analysis of primary petitions used for marketing authorization “may not exceed the period of 90 (ninety) business days.” On non-response, development may begin once ethics approvals are in place; the authority may request additional information only once — suspending but not resetting the clock — and Good Clinical Practice (GCP) inspections remain available.2
The June release ran on the drug track because the implementing regulation existed only for drugs: RDC 945/2024 applies to medicinal-product trials and excludes devices. Its Article 52 counts 90 business days from the DEEC and, on silence, releases dossiers by lapse of term — the mechanism RE 2,413 used.3
Devices run on a different implementing rule, RDC 837/2023, in force since January 2024.4, 5 It requires a Medical Device Clinical Investigation Dossier (Dossiê de Investigação Clínica de Dispositivo Médico, or DICD) for unregistered Class III/IV devices and registered devices studied for a new indication; Class I and II studies fall outside ANVISA’s scope.4, 6
The two clocks are not identical. Drug petitions run on 90 business days; for devices, Article 8 of RDC 837 counts 90 calendar days from ANVISA’s receipt of the DICD — a shorter window, so a sponsor who assumes the timelines match will miscount.2, 3, 4
RE 2,413 is administrative practice, not binding precedent, and it triggers no automatic approval for devices — the device deadline lives in RDC 837, not the RDC 945 that RE 2,413 invoked. The same statute (Article 58) sits above both pathways, so treat the RDC 837 clock as a real, if untested, planning parameter confined to a properly scoped DICD, with GCP inspection authority intact.1, 2, 3, 4
The Fork Before The Clock
Before counting days, decide which pathway the study is on — the fork turns on intended regulatory use, not the phase label. RDC 837 Articles 1 and 2 scope the resolution to investigations whose results may support registration of Class III and IV devices or otherwise compose the device’s regulatory clinical evaluation; Article 4’s DICD requirement operates within that scope.4 ANVISA said as much when announcing the rule: only investigations whose results may support such registration are subject to submission.5
The consequence is a clean split. Registration-directed work — pivotal, FIH, EFS, pilot, or proof-of-concept — with an unregistered Class III/IV device or a registered device studied for a new indication requires a DICD. The same study, genuinely not intended to support ANVISA registration, market clearance, or another Brazilian regulatory purpose, may — on a reading of Articles 1 and 2 that ANVISA has not expressly confirmed — fall outside DICD review. Intent is judged from the protocol, the development plan, and how the study is run.4 ,5
Outside DICD does not mean outside ANVISA. A non-registration study still requires ethics review under Brazil’s research ethics system and compliance with Law 14,874/2024’s human subject protections.2 And where the device or study materials are imported, ANVISA’s express favorable sanitary manifestation is required before customs clearance under the research import pathway of RDC 172/2017.7
How The Import Permit Works Without A DICD
A foreign-made investigational device still crosses a border, so it needs sanitary import clearance obtained without any DICD. First, appoint a qualified Brazilian legal entity importer and confirm which establishment authorizations it must hold — including, where applicable, an operating authorization (Autorização de Funcionamento de Empresa, or AFE); if the device is made locally with no import, the route is moot. Second, obtain current ethics committee approval before import.7 Third, file in Portal Único/Integrated Foreign Trade System (SISCOMEX) via RDC 172’s scientific, technological, or human subject research route — not by attaching a DICD resolution. ANVISA’s current device import manual lists subject 90458 for devices and in vitro diagnostics imported for scientific or technological research via an import license (LI) and an LPCO (license, permit, certificate, and other documents) record; the manual and a webinar note LPCO model I00038. Both are framed around scientific or technological research, so confirm with ANVISA at filing that they cover a human subject device import — or which subject and model do — as mismatched codes are denied.8, 9 Fourth, support it with the ethics approval, the sanitary inspection and release petition, a commercial invoice, the bill of lading, a digitally signed responsibility term, and quantities matching the approved protocol (with prior imports disclosed).7 ,10 Fifth, ANVISA must issue an express favorable sanitary manifestation before customs release — a per-shipment border clearance, not a retroactive DICD approval and not permission to use the data for registration.7 RDC 613/2022 limits this import to SISCOMEX or express shipment; postal entry is no longer allowed.10 The paradox resolves: the study sits outside DICD review while the imported product still gets ANVISA border and sanitary review through a separate legal pathway.7, 8
Two cautions close the fork. First, data generated outside DICD may not support a later ANVISA registration without prospective engagement; if Brazilian registration is a realistic contingency, run under DICD from the start or seek RDC 837 Article 5 guidance before enrollment.4 Second, Article 4 is categorical on its face and ANVISA’s FAQ does not expressly answer the non-registration Class III/IV FIH fact pattern — another reason to seek Article 5 guidance rather than self-classify, as a prior Med Device Online article urged.4, 6, 11
Action Checklist: Build A DICD That Can Survive Day 90
This checklist applies to registration-directed studies that need a DICD. Article 11 of RDC 837 lists what a DICD must contain; Article 12 requires everything to be filed digitally in text-searchable form.4 Build to that standard:
- The DICD petition form, on ANVISA’s model, filed through the Solicita system4 ,6
- Proof of payment (or exemption) of the inspection fee4
- The investigator’s brochure and a prior human experience and post-market safety summary, including foreign data4
- The investigational device dossier in the required annex format, with a GCP-compliant clinical investigation plan4
- Proof of trial registration; if unavailable at filing, it may follow at start-notification4
- Every file text-searchable, since non-searchable scans invite avoidable technical requirements4
One caution closes the list. Substantial amendments may be filed after DICD submission, but under Article 21 of RDC 837 their implementation must await ANVISA’s manifestation — except amendments eliminating immediate risks to participants, which may be implemented and notified at once. That is the exception to any “silence means go” reflex.4, 6
Choose The Pathway Before Counting Days
Three questions structure the decision. First, is the data intended for Brazilian regulatory use? Class I/II devices, or a registered device studied for its approved indication, fall outside DICD but need ethics review and, when imported, an import pathway.4 ,6 Second, if yes, is the DICD day-90-ready under Article 11, or merely filed? Because RDC 837, unlike RDC 945, does not spell out how a technical requirement affects the 90-calendar-day count, assume a single technical requirement can erase the deadline.4 Third, if no — a non-registration study — are ethics, import, human subject protections, and written Article 5 scope confirmation addressed before first import or enrollment? For a foreign-made device, map the RDC 172 import dossier before ethics approval issues so the LPCO can move without waiting for a DICD document that will never exist.4, 7
Ethics review is migrating to Brazil’s Sistema Nacional de Ética em Pesquisa (SINEP); under Decree 12,651/2025 it comprises the Instância Nacional de Ética em Pesquisa (INAEP) and Research Ethics Committees (CEPs).12 Accredited CEPs may review high-risk protocols and credentialed CEPs low- and moderate-risk research; INAEP’s February 2026 guidance calls procedures still in consolidation, so confirm CEP routing before filing.13
Import is the practical chokepoint: even after day 90, a registration-directed device still depends on the DOU-published DICD import document in a non-response case and on sanitary release through SISCOMEX. No device-specific example of that document issuing after non-response was found — an absence finding, not proof none exists.4
Avoid two temptations: do not assume Brazil is categorically faster than the U.S. FDA or European pathways — the evidence is about deadline discipline, not global speed — and do not budget on unverified savings percentages. The defensible claim is narrower: a statutory deadline that a complete submission can turn into schedule certainty.
Conclusion
RE 2,413 is a drug story with a device lesson: not that devices enjoy automatic approval — they do not — but that Brazil’s deadlines have teeth, and the law creating them was never limited to drugs.1, 2 The winning move depends on the fork. A registration-directed Class III or IV program should file a complete text-searchable DICD and advance ethics, import, and sites in parallel. A genuinely non-registration FIH, EFS, or proof-of-concept study can fall outside DICD clinical investigation review when that scope is confirmed, but ethics approval, import clearance where products are imported (through RDC 172 for a confirmed non-DICD study), human subject protections, and written Article 5 guidance still apply, and no sponsor should label a study “non-registration” merely to avoid oversight. When ANVISA’s clock runs out, only a prepared sponsor is there to catch it.
References
1. Resolução-RE nº 2.413, de 17 de junho de 2026, Diário Oficial da União, Edição 112, Seção 1, p. 204 (published June 18, 2026). https://www.in.gov.br/web/dou/-/resolucao-re-n-2.413-de-17-de-junho-de-2026-713242393 Certified image: https://pesquisa.in.gov.br/imprensa/servlet/INPDFViewer?jornal=515&pagina=204&data=18/06/2026&captchafield=firstAccess
2. Law No. 14,874 of May 28, 2024 (official English translation), ANVISA. https://www.gov.br/anvisa/en/rules-and-regulations/arquivos/lei-14874-2024-e.pdf
3. Resolution RDC No. 945 of November 29, 2024 (official English translation), ANVISA. https://www.gov.br/anvisa/en/rules-and-regulations/arquivos/rdc-945-2024-e.pdf
4. Resolution RDC No. 837 of December 13, 2023, ANVISA. https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000837&seqAto=000&valorAno=2023&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true
5. Anvisa atualiza regras sobre investigações clínicas com dispositivos médicos, ANVISA (December 15, 2023). https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/anvisa-atualiza-regras-sobre-investigacoes-clinicas-com-dispositivos-medicos
6. Perguntas e Respostas — Pesquisa Clínica com Dispositivos Médicos, ANVISA (November 13, 2024). https://www.gov.br/anvisa/pt-br/acessoainformacao/perguntasfrequentes/produtosparasaude/perguntas-e-respostas-pesquisa-clinica-com-dispositivos-medicos
7. Resolution RDC No. 172 of September 8, 2017, ANVISA (Articles 5–7 and 11–13). https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2017/rdc0172_08_09_2017.pdf
8. Manual de Importação de Dispositivo Médico, ANVISA. https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/portos-aeroportos-e-fronteiras/guias-e-manuais/manual-de-importacao-de-dispositivo-medico.pdf
9. Perguntas e Respostas — Webinar Importação e Exportação (produtos não sujeitos/pesquisa científica), ANVISA. https://www.gov.br/anvisa/pt-br/assuntos/educacaoepesquisa/webinar/importacao-e-exportacao/arquivos/PerguntaseRespostasWebinarNosujeitos.pdf
10. Resolution RDC No. 613 of March 9, 2022 (amending RDC No. 172/2017), ANVISA. https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000613&seqAto=000&valorAno=2022&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true See also: Relatório de Análise de Impacto Regulatório — RDC nº 613/2022, ANVISA. https://www.gov.br/anvisa/pt-br/assuntos/regulamentacao/avaliacao-do-resultado-regulatorio/sei_25351-925111_2021_12-relatorio-613_2022.pdf
11. J. Martinez-Clark, “Brazil’s Regulatory Revolution: How New Laws Are Transforming Medical Device Clinical Trials,” Med Device Online (July 3, 2025). https://www.meddeviceonline.com/doc/brazil-s-regulatory-revolution-how-new-laws-are-transforming-medical-device-clinical-trials-0001
12. Decreto nº 12.651, de 2025, Presidência da República. https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2025/Decreto/D12651.htm
13. Perguntas e Respostas — INAEP, Ministério da Saúde (February 10, 2026). https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/publicacoes/perguntas-respostas-inaep
About The Author:
Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the Global Trial Accelerators podcast. He has a bachelor's degree in electronics engineering (BSEE) and a master's degree in business administration (MBA).