Medical Device Regulation in Brazil
ANVISA regulates medical devices (Produtos para a Saúde) under RDC 751/2022, which replaced RDC 185/2001. Brazil uses a GHTF-aligned four-class risk-based system. ANVISA is both an IMDRF member and an MDSAP participant, making it one of the more internationally harmonized regulators in Latin America.
Recent Regulatory Updates
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Anvisa bans unregistered sanitizing products.
Anvisa bans unregistered tattoo equipment and inks
New standardized AER terminology with codes.
Sources Tracked by Qalico
Qalico continuously monitors 8 references across guidelines, regulations, and standards for Brazil.
Guidelines
Device Classification
Class I (lowest risk): e.g., bandages, examination gloves. Class II: e.g., needles, syringes. Class III: e.g., ventilators, haemodialysis equipment. Class IV (highest risk): e.g., cardiac stents, implantable pacemakers. Classification follows GHTF/IMDRF rules aligned with international standards.
Official classification guidance →Standards & Key Principles
Applicable Standards
Key Principles
- GHTF/IMDRF-harmonized four-class system
- GMP (Boas Práticas de Fabricação – BPF) certificate mandatory
- Brazilian Authorized Representative required for foreign manufacturers
- Registro (Class III/IV) vs. Cadastro (Class I/II) pathways
- SOLICITA electronic platform for all regulatory submissions
- MDSAP participant: shared audits with FDA, Health Canada, TGA, PMDA
Pre-Market Requirements
Simplified registration via SOLICITA. Declaration of conformity, GMP certificate, labeling review. Faster pathway for lower-risk devices.
Full registration: technical dossier, clinical evidence, GMP Certificate, labeling, risk/benefit analysis submitted to ANVISA.
Mandatory for all device classes. Issued by ANVISA after inspection or via MDSAP audit report. Valid for 2 years.
Post-Market Requirements
Deaths/serious injuries reported to ANVISA via Notivisa system within 7 days; other events within 30 days.
Ongoing monitoring of marketed devices; queixas técnicas and adverse events reported to ANVISA.
ANVISA notified of all voluntary or compulsory recalls; ANVISA can mandate recalls. Notices published publicly.
International Recognition & Reliance
MERCOSUR mutual recognition: devices registered in MERCOSUR countries benefit from harmonized procedures.
MDSAP audit reports accepted by ANVISA, reducing duplicative GMP inspections.