RDC 752/2022 — GMP (CBPF)
RDC 752/2022 establishes the Good Manufacturing Practices (GMP) requirements for medical device manufacturers and importers in Brazil — forming the basis for the CBPF (Certificado de Boas Práticas de Fabricação).
RDC 752/2022 is closely aligned with ISO 13485:2016 and covers:
- Quality management system requirements;
- Management responsibility;
- Resource management;
- Product realisation (design, purchasing, production, service);
- Measurement, analysis and improvement (internal audit, CAPA, complaints); and
- Documentation and record keeping.
For foreign manufacturers, an ISO 13485 certificate from an accredited certification body is generally accepted as equivalent evidence of GMP compliance.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.