Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
Brazil is Latin America's largest clinical trials market with 210M+ patients, world-class medical centers, and ANVISA — a WHO-listed regulatory authority. Law 14874 (2024) and RDC 837 have dramatically streamlined approval timelines, making Brazil more accessible than ever for MedTech, Biopharma, and Radiopharma startups.
Brazil represents the largest healthcare market in Latin America and the 8th largest in the world. With over 210 million people, Brazil offers unmatched patient diversity — a critical advantage as the FDA increasingly requires diversity action plans for pivotal trials under the 2024 FDORA guidance. Clinical data from Brazil's ethnically diverse population strengthens your regulatory submission by demonstrating device performance across demographic groups.
ANVISA (Agência Nacional de Vigilância Sanitária) is a WHO-listed stringent regulatory authority, meaning approvals carry significant weight with global regulators including the FDA and EMA. The landmark Law 14874 (May 2024) eliminated the legacy double-approval system (CONEP + CEP) for most studies and capped ethics reviews at 30 business days — reducing what was historically a 6-month process to 6–10 weeks.
bioaccess® operates across Brazil's top medical centers in São Paulo, Rio de Janeiro, and other major cities. Our Brazilian regulatory team navigates ANVISA's clinical investigation pathway (RDC 837/2023) and coordinates with institutional CEPs to ensure rapid approvals. For early feasibility studies not intended for Brazilian market clearance, only CEP approval is required — no CONEP review needed.
ANVISA's Resolution RDC 837/2023 governs clinical investigations of medical devices in Brazil. The regulation requires submission of a clinical investigation dossier including the investigator brochure, protocol, informed consent, insurance documentation, and evidence of GMP compliance. For novel devices, ANVISA conducts a scientific review that runs concurrently with ethics committee evaluation. bioaccess® manages the entire ANVISA submission process in Portuguese.
Law 14874 (May 2024) transformed Brazil's ethics review system. Ethics committees (CEPs) are now capped at 30 business days for review. The legacy requirement for CONEP (national ethics commission) review has been eliminated for most clinical investigations. For early feasibility studies, only the institutional CEP at the research site is required. A critical operational note: the specific CEP cannot be determined until the research site and investigator are selected, as committees are affiliated with the host institution.
Brazil's population is one of the most ethnically diverse in the world, with significant African, European, Indigenous, and Asian ancestry. This diversity is increasingly valuable as the FDA requires diversity action plans for pivotal device studies under FDORA 2022 Section 3602. FIH data from Brazil demonstrates that your device performs safely across diverse populations, strengthening subsequent US regulatory submissions.
Brazil accepts non-GLP R&D-grade preclinical data for early feasibility investigations, including high-risk Class III devices. This is a significant advantage for startups that have bench and animal data but have not yet completed formal GLP studies. bioaccess® advises on the minimum preclinical package required for ANVISA and CEP submission based on your device risk classification.
| Metric | Brazil 🇧🇷 | United States 🇺🇸 | Europe (EU) 🇪🇺 |
|---|---|---|---|
| Regulatory/ethics approval | 6–10 weeks (ANVISA + CEP, Law 14874) | 6–12 months (IDE + IRB) | 3–6 months (per-country CA + EC) |
| Cost per patient | $20K–$35K | $40K–$75K | $35K–$60K |
| CONEP review for EFS | Not required (Law 14874) | N/A | Varies by country |
| FDA data acceptance | Eligible for submission/review — 21 CFR 812.28 (ISO 14155) | Native | Yes, with justification |
| Regulatory authority | ANVISA — WHO-listed stringent | FDA | EMA / national CAs |
| Patient population & diversity | 210M+, high ethnic diversity (FDA DAP) | 330M+ | ~450M (fragmented) |
| Non-GLP preclinical data for EFS | Accepted | Case-by-case | Varies by country |
Ranges reflect bioaccess® first-in-human medical device studies. Actual costs and timelines vary by device complexity, therapeutic area, and monitoring requirements.
Under the reformed regulatory framework (Law 14874 and RDC 837), combined ANVISA + ethics committee approval typically takes 6–10 weeks. Ethics committees are now capped at 30 business days. bioaccess® manages the entire process in Portuguese, from dossier preparation to regulatory correspondence.
No. Under the current framework, early feasibility studies that are not intended for Brazilian market clearance require only institutional CEP (ethics committee) approval. CONEP review has been eliminated for most clinical investigations under Law 14874. This significantly reduces approval timelines.
Per-patient costs in Brazil range from $20,000–$35,000 depending on device complexity, therapeutic area, and monitoring requirements. While slightly higher than Colombia or Panama, Brazil offers the advantage of larger patient populations, ethnic diversity for FDA compliance, and ANVISA's stringent regulatory credibility.
Yes. Brazil accepts non-GLP R&D-grade preclinical data for early feasibility investigations, including high-risk Class III devices such as bio-resorbable neurosurgical materials. This is a significant advantage for startups that have bench and animal data but haven't completed formal GLP studies.
Brazil's population is one of the most ethnically diverse in the world. FIH data from Brazil demonstrates device safety and performance across African, European, Indigenous, and Asian ancestry groups. This directly supports the FDA's diversity action plan requirements under FDORA 2022 Section 3602, strengthening your subsequent US pivotal submission.
Brazil excels in cardiology, neurosurgery, oncology, orthopedics, and ophthalmology. São Paulo's Hospital das Clínicas is one of the largest medical complexes in Latin America. bioaccess® has pre-qualified sites with experienced investigators across these therapeutic areas, including hospitals that accommodate sponsor observation teams in the OR.
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