Brazil clinical trial regulatory guide

Regulator: ANVISA (Agência Nacional de Vigilância Sanitária)

Brazil is the largest pharmaceutical and medical device market in Latin America. ANVISA maintains rigorous regulatory standards aligned with international best practices. While approval timelines are longer than some LATAM peers, Brazil offers access to a massive, diverse patient population and world-class clinical research infrastructure.

Approval process

1. CEP/CONEP Submission. Submit to local Research Ethics Committee (CEP) via Plataforma Brasil. Complex or high-risk studies require CONEP (national ethics) review.
2. ANVISA Clinical Trial Authorization. Submit via ANVISA's electronic portal. Includes protocol, IB, device dossier, GMP certificates, and ethics approval.
3. Import Authorization. Obtain ANVISA import license for investigational products.
4. Site Contracts & Activation. Finalize institutional agreements and site training.

Ethics requirements

• Mandatory submission via Plataforma Brasil (online system)
• CEP (local ethics) review required; CONEP for high-risk studies
• Informed consent in Portuguese, following Resolution 466/2012
• Insurance coverage for all participants is mandatory
• Continuing review at the interval the ethics committee sets

Documentation requirements

• Protocol and amendments in Portuguese
• Investigator brochure (Portuguese translation)
• Device technical file with risk analysis
• GMP/ISO 13485 certificates
• Mandatory insurance documentation
• ANVISA-specific application forms

Device registration

ANVISA uses a risk-based classification (Classes I, II, III, IV). Registration requires a Brazilian Registration Holder (BRH), extensive technical documentation, and may require in-country testing. Timelines vary by study (we confirm it per protocol) depending on risk class. ANVISA's MDSAP participation can streamline certain aspects.

FDA acceptance of Brazil data

FDA accepts Brazilian clinical data under 21 CFR 812.28 when generated under ICH-GCP. Brazil's ANVISA standards are highly regarded by the FDA, and data from Brazilian sites has been used in multiple successful FDA submissions. The key requirement is demonstrating protocol compliance with ISO 14155:2020.

Key contacts

• ANVISA — National Health Surveillance Agency
• CONEP — National Research Ethics Commission

Frequently asked questions

Why is Brazil's approval timeline longer?

ANVISA conducts thorough reviews and the dual-layer ethics system (CEP + CONEP) adds time but ensures high standards.

Is Plataforma Brasil mandatory?

Yes, all clinical trial ethics submissions must go through this national online platform.

Can I run a FIH trial in Brazil?

Brazil’s longer timelines make it a heavier lift for a first device study. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia. bioaccess® runs first-in-human studies in Colombia now, devices included.

Does ANVISA participate in MDSAP?

Yes, Brazil is a participating member of the Medical Device Single Audit Program (MDSAP).

What insurance is required?

Sponsors must provide comprehensive insurance covering all participants for the duration of the trial plus follow-up.

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