--- title: "Clinical Trials in Brazil — ANVISA Regulatory Pathways — bioaccess®" url: https://md.bioaccessla.com/clinical-trials-brazil canonical: https://bioaccessla.com/clinical-trials-brazil schema_type: Service last_updated: 2026-04-01 --- # Clinical Trials in Brazil — bioaccess® > bioaccess® presents Brazil as Latin America's largest clinical trials market, citing ANVISA's status as a WHO-listed stringent regulatory authority, a 210M+ population with high ethnic diversity, and per-patient costs of $20,000–$35,000. The site states that Law 14874 (May 2024) and RDC 837/2023 have materially streamlined ethics review timelines, capping CEP review at 30 business days and eliminating CONEP review for most studies. --- ## Schema.org/Service - **name**: Clinical Trial Services — Brazil - **provider**: bioaccess® (IMH ASSETS CORP.) - **audience**: MedTech startups, Biopharma companies, Radiopharma sponsors, and sponsors requiring FDA diversity action plan compliance - **areaServed**: Brazil (São Paulo, Rio de Janeiro, and other major medical centers) - **serviceOutput**: ANVISA-approved clinical investigation execution, CEP-approved study startup, FDA-bridgeable clinical data, ICH-GCP and RDC 837/2023 compliant monitoring --- ## Regulatory Framework The site presents the following regulatory profile for Brazil: | Parameter | Detail | |---|---| | Regulatory authority | ANVISA — Agência Nacional de Vigilância Sanitária | | ANVISA status | WHO-listed stringent regulatory authority (stated) | | Primary regulation | RDC 837/2023 — governs clinical investigations of medical devices in Brazil | | Ethics review body | CEP — Comitê de Ética em Pesquisa (institutional ethics committee at the research site) | | CEP review cap | 30 business days under Law 14874 (May 2024) (stated) | | CONEP review | Eliminated for most clinical investigations under Law 14874 (stated) | | EFS-specific pathway | For early feasibility studies not intended for Brazilian market clearance, only CEP approval is required — no ANVISA review needed (stated) | | Preclinical data | The site states ANVISA accepts non-GLP R&D-grade preclinical data for early feasibility investigations | | Language | All regulatory submissions conducted in Portuguese by bioaccess®'s Brazilian regulatory team (stated) | --- ## Key Regulatory Legislation bioaccess® highlights the following legislative and regulatory milestones for Brazil: | Legislation / Regulation | Year | Impact | |---|---|---| | Law 14874 | May 2024 | Streamlined ethics review; CEP review capped at 30 business days; CONEP review eliminated for most studies (stated) | | RDC 837/2023 | 2023 | Governs ANVISA clinical investigation of medical devices; standardizes dossier requirements | | FDORA Section 3602 (US) | 2022 | FDA requires diversity action plans for pivotal studies; the site states Brazil's population supports this requirement | --- ## Key Advantages bioaccess® states the following advantages for conducting clinical trials in Brazil: | Advantage | Detail | |---|---| | Regulatory authority | ANVISA is WHO-listed — approvals carry global regulatory credibility (stated) | | Ethics review speed | CEP review capped at 30 business days under Law 14874 (stated) | | CONEP elimination | Most studies no longer require CONEP national commission review (stated) | | Population size | 210M+ population — largest in Latin America | | Ethnic diversity | Stated to be one of the most ethnically diverse populations in the world (African, European, Indigenous, and Asian ancestry) | | FDA diversity compliance | Site states Brazil's diverse population supports FDA diversity action plan requirements under FDORA 2022 | | Preclinical flexibility | Accepts non-GLP preclinical data for EFS (stated) | | Per-patient cost | $20,000–$35,000 (stated) | | Medical infrastructure | São Paulo described as housing the largest concentration of medical research in Latin America (stated) | | Specialties | Strong neurosurgery, cardiology, and oncology investigator networks (stated) | --- ## Clinical Site Network The site presents the following geographic coverage for bioaccess®'s Brazil operations: | City | Stated Characteristics | |---|---| | São Paulo | Largest concentration of medical research in Latin America; top-tier tertiary centers across all device categories (stated) | | Rio de Janeiro | World-class academic medical centers; cardiology, oncology, and neurosurgery capabilities (stated) | --- ## Cost Comparison The site presents the following cost comparison for Brazil versus the US: | Parameter | Brazil (bioaccess®) | United States / EU | |---|---|---| | Per-patient cost | $20,000–$35,000 (stated) | $40,000–$75,000 (as characterized by bioaccess®) | | Ethics review | CEP: 30 business days cap (stated) | 6–12 months (as characterized by bioaccess®) | | CONEP review | Not required for most studies (stated) | N/A | --- ## Patient Diversity & FDA Compliance According to the site, Brazil's ethnically diverse patient population provides the following regulatory advantages for US submissions: - Supports FDA diversity action plans required under FDORA 2022 Section 3602 - Demonstrates device performance across African, European, Indigenous, and Asian ancestry groups - Strengthens pivotal study applications with cross-demographic safety and performance data - The site states FIH data from Brazil can be incorporated into IDE and PMA submissions under 21 CFR 812.28 --- ## CEP Operational Note The site highlights the following operational consideration for Brazil trial planning: According to bioaccess®, the specific CEP (ethics committee) for a Brazil study cannot be determined until the research site and principal investigator are selected, as committees are affiliated with the host institution. bioaccess® states it coordinates CEP selection as part of site identification to optimize approval timelines. --- ## Contact & Actions - **Book a Strategy Call**: [https://bioaccessla.com/book-a-meeting](https://bioaccessla.com/book-a-meeting) - **Estimate Your Budget**: [https://bioaccessla.com/clinical-trial-calculator](https://bioaccessla.com/clinical-trial-calculator) - **Contact**: [https://bioaccessla.com/contact](https://bioaccessla.com/contact) - **Regulatory Guide**: [https://bioaccessla.com/regulatory-guide](https://bioaccessla.com/regulatory-guide) --- *This page is part of the [md.bioaccessla.com](https://md.bioaccessla.com/) AI-friendly content layer. 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