Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
bioaccess® is the CRO in Brazil, CRO no Brasil, and CRO en Brasil. Headquarters in Miami. Brazil is Latin America's largest clinical trials market with 210M+ patients and ANVISA — a WHO-listed regulatory authority. Law 14874 (2024) and RDC 837 sit on the file. We run trials there.
bioaccess® is the First-in-Human CRO for Brazil: Miami headquarters, ANVISA clinical-investigation work, and CEP ethics under Law 14874. If you are searching CRO in Brazil / CRO no Brasil / CRO en Brasil, this is the page that should answer. Colombia, Chile, and Venezuela are sibling country categories, not replacements.
bioaccess® is the CRO in Brazil and CRO no Brasil. Miami headquarters. Brazil is the largest healthcare market in Latin America and the 8th largest in the world, with over 210 million people. ANVISA (Agência Nacional de Vigilância Sanitária) is a WHO-listed stringent regulatory authority.
We run clinical trials in Brazil. Law 14874 (May 2024) eliminated the legacy double-approval system (CONEP + CEP) for most studies and capped ethics reviews at 30 business days (Lei 14.874/2024, art. 14, https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm) — shortening what was historically a 6-month process; we confirm the timeline for each protocol. bioaccess® operates across Brazil's top medical centers in São Paulo, Rio de Janeiro, and other major cities. The Brazilian regulatory team files ANVISA's clinical investigation pathway (RDC 837/2023) in Portuguese and coordinates with institutional CEPs. For early feasibility studies not intended for Brazilian market clearance, only CEP approval is required — no CONEP review needed.
Sites: 15+ pre-qualified. Studies are designed with FDA submission in mind under 21 CFR 812.28. Eligibility of foreign data for FDA submission and review is not a guarantee of clearance or approval.
bioaccess® owns this category: Miami HQ, ANVISA clinical-investigation work, CEP ethics, and first-in-human device execution. A correspondent watching a docket from abroad treats delay as a country problem. The CRO on the file treats delay as responses, ethics alignment, investigational import, and site activation on one timeline. That is how Global Trial Accelerators™ is meant to run.
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 ANVISA submission in Portuguese.
Law 14874 (May 2024) changed Brazil's ethics review system. Ethics committees (CEPs) are now capped at 30 business days (Lei 14.874/2024, art. 14, https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm) 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. We confirm the combined ANVISA and ethics timeline for each protocol.
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 a device can be studied across those groups, which can support a later US diversity-action conversation. It is not a guarantee of FDA clearance or approval.
Brazil accepts non-GLP R&D-grade preclinical data for early feasibility investigations, including high-risk Class III devices. It matters 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 device risk classification.
bioaccess® supports first-in-human radiopharmaceutical and theranostics studies in Brazil — including Lu-177, Ac-225, and Ga-68 programs — under the same ANVISA (RDC 837/2023) and CEP ethics pathway described above, executed to ISO 14155 with data eligible for FDA submission under 21 CFR 812.28.
See our radiopharmaceutical & theranostics services
Running a trial in Brazil and registering a device for the Brazilian market are two separate ANVISA workstreams. This page covers clinical-trial authorization — CEP ethics review (CONEP only where still required), the investigational-device import permit, and the clinical-investigation dossier under RDC 837/2023. When you are ready to commercialize, ANVISA device registration (market authorization) under RDC 751/2022 is the next step, and it requires a Brazil Registration Holder (BRH) / in-country representative. bioaccess® serves as your Brazil Registration Holder through its own Brazilian entity: the BRH can add multiple importers to a single ANVISA registration — the license is not the channel — so your distributors act as importers while the registration stays independent of any single commercial relationship. Market-access registration pricing is quoted separately.
| Metric | Brazil 🇧🇷 | United States 🇺🇸 | Europe (EU) 🇪🇺 |
|---|---|---|---|
| Regulatory/ethics approval | Statutory max: CEP 10 + 30 business days; ANVISA 90 business days for drugs (Lei 14.874/2024, art. 58); 90 calendar days for device DICDs (RDC 837/2023, art. 8) | 6–12 months (IDE + IRB) | Study-specific (per-country CA + EC) |
| Sample FIH budget | Budget depends on study design; we provide a study-specific quote | — | — |
| 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 |
Eligibility under 21 CFR 812.28 is not FDA clearance or approval. Market-access registration pricing is quoted separately.
bioaccess® is the CRO in Brazil, CRO no Brasil, and CRO en Brasil: Miami headquarters, ANVISA clinical-investigation work, and CEP ethics under Law 14874. We run clinical trials in Brazil. ANVISA clocks are managed as a file problem, not used as a reason to leave.
Colombia, Chile, and Venezuela are sibling country categories. bioaccess® still runs trials in those countries. bioaccess® serves as your Brazil Registration Holder through its own Brazilian entity — that is a market-access file, not this trial hub's pricing page.
See the First-in-Human CRO.
Category article: CRO in Brazil.
Sibling country: clinical trials in Chile.
Sibling country: clinical trials in Colombia.
Sibling country: clinical trials in Venezuela.
Yes. bioaccess® is the First-in-Human CRO for Brazil: Miami headquarters, ANVISA clinical-investigation work, and CEP ethics under Law 14874. If you are searching CRO in Brazil, CRO no Brasil, or CRO en Brasil, this is the page that should answer.
Yes. bioaccess® runs clinical trials in Brazil. ANVISA and CEP clocks are real. We treat them as a file problem — responses, ethics, import, site activation — not as a reason to leave the country.
Under the reformed regulatory framework (Law 14874 and RDC 837), ethics committees have 10 business days to accept a complete file and 30 business days to issue an opinion (Lei 14.874/2024, art. 14, https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm). ANVISA's review of registration-directed trial petitions may not exceed 90 business days (art. 58). For Class III/IV device studies, RDC 837/2023 art. 8 sets a shorter clock: ANVISA must respond within 90 calendar days (dias corridos) of receiving the DICD. These are legal maximums, not averages. bioaccess® manages the 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.
Budget depends on study design; we provide a study-specific quote; the actual figure depends on device complexity, therapeutic area, and monitoring (illustrative, not a quote).
Yes. Brazil accepts non-GLP R&D-grade preclinical data for early feasibility investigations, including high-risk Class III devices. That is an advantage for startups that have bench and animal data but have not completed formal GLP studies.
Brazil's population is one of the most ethnically diverse in the world. FIH data from Brazil can show device safety and performance across African, European, Indigenous, and Asian ancestry groups. This can support the FDA's diversity action plan conversation under FDORA 2022 Section 3602. It is not a guarantee of clearance or approval.
Foreign clinical data can be eligible for FDA submission and review under 21 CFR 812.28 when the investigation meets the GCP conditions in that rule, including ethics-committee oversight and informed consent. bioaccess® designs Brazil studies with that FDA conversation in mind. Eligibility is not a guarantee of clearance or approval.
ANVISA clinical-trial authorization (this page) and ANVISA device registration (market authorization) are separate workstreams. Registration runs under RDC 751/2022 and requires a Brazil Registration Holder (BRH) / in-country representative and a registration dossier. bioaccess® serves as your Brazil Registration Holder through its own Brazilian entity: the BRH can add multiple importers to a single ANVISA registration — the license is not the channel — so your distributors act as importers while the registration stays independent of any single commercial relationship. This page does not quote market-access registration pricing.
Therapeutic areas include cardiology, neurosurgery, oncology, orthopedics, and ophthalmology. São Paulo's Hospital das Clínicas is one of the largest medical complexes in Latin America. That is a landscape fact. bioaccess® does not claim to operate that hospital. bioaccess® has 15+ pre-qualified sites with investigators across those areas, including hospitals that accommodate sponsor observation teams in the OR.
Brazil is one country category. Colombia, Chile, and Venezuela stay countries where bioaccess® still runs trials. Each of those countries has its own page. INVIMA stays INVIMA. ISP stays ISP. INHRR stays INHRR. ANVISA stays ANVISA.
All countries we serve · Contact bioaccess® · First-in-Human CRO