🇧🇷Brazil Medical Device Regulations

Medical Device Sanitary Control and Import Procedures

Requirements for import licenses, customs clearance, and regulatory compliance for medical devices imported into Brazil.

Medical Device Regularization and Compliance

Requirements for medical device regularization, quality management, technical documentation, and post-market surveillance.

Leveraging Foreign Regulatory Authorizations (AREE)

Streamlines evaluation for Class III/IV devices already approved by GHTF founding members (USA FDA, Canada, Japan, Australia TGA). Estimated 30% reduction in ANVISA review time.

In Vitro Diagnostic (IVD) Medical Devices

Regulation for IVD medical devices including classification (Class I-IV), registration pathways, self-testing requirements, and companion diagnostics. Replaced RDC 36/2015.

UDI Implementation Timeline Extension

Amends RDC 591/2021 extending UDI deadlines by one year. Class IV: July 2025, Class III: January 2026, Class II: January 2027, Class I: January 2028.

GMP Certificate Extension for MDSAP Manufacturers

Extends B-GMP certificates from 2 to 4 years for manufacturers with MDSAP certificates. Amends RDC 497/2021. Reduces regulatory costs and ANVISA inspection burden.

Clinical Studies Guidelines for Medical Devices

Establishes guidelines for clinical studies conducted within Brazil for medical devices. Defines requirements for clinical investigation protocols and ethical approvals.

Medical Device Registration and Classification

Core regulation for medical device classification (Class I-IV) and registration pathways (notification vs. marketing authorization) in Brazil.

Good Manufacturing Practice (GMP) for Medical Devices

GMP requirements for medical device manufacturers including quality management system, design controls, and production processes. Replaced RDC 16/2013.

Unique Device Identification (UDI) System

Brazil's UDI system requiring unique identifiers, barcode labels, and GUDID database submission for improved device traceability.