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 13485:2016 certificate from an accredited certification body (INMETRO-recognised or equivalent) is generally accepted as equivalent evidence of GMP compliance under RDC 752/2022 for registration purposes.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.