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GMP for Domestic Manufacturers

Brazilian manufacturers of medical devices must comply with RDC 752/2022 and obtain a CBPF issued by ANVISA or the state VISA body where the manufacturing facility is located.

The CBPF inspection process​

  1. Application — submit a CBPF application via Peticionamento Eletrônico.
  2. Documentation review — ANVISA reviews the quality system documentation.
  3. Inspection — ANVISA or state VISA inspectors conduct a physical site inspection, reviewing facilities, processes, documentation, and records.
  4. Inspection report — inspectors issue a report identifying any non-conformities.
  5. Corrective action — the manufacturer must address non-conformities within the specified timeframe.
  6. CBPF issuance — upon satisfactory resolution, ANVISA issues the CBPF.

The CBPF must be kept current — it has a defined validity period and must be renewed before expiry.

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.

The CBPF is typically valid for 2 years from the date of issuance. Manufacturers should submit renewal applications at least 90 days before the current CBPF expires to avoid a lapse in certification.