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GMP for Importers — Verifying Foreign Manufacturer Compliance

Brazilian importers who hold medical device registrations in their own name are responsible for ensuring that the foreign manufacturer whose devices they import complies with GMP requirements.

How importers verify foreign manufacturer GMP compliance​

  1. Obtain the foreign manufacturer's current ISO 13485 certificate or equivalent GMP certification (e.g., EU notified body certificate, FDA establishment registration and QMSR compliance).
  2. Include the GMP certificate in the Registro/Cadastro dossier submitted to ANVISA.
  3. Conduct periodic supplier audits of the foreign manufacturer — this is a requirement of RDC 752/2022's purchasing controls section.
  4. Keep the GMP certificate on file and update it when renewed.

ANVISA may conduct inspections at foreign manufacturer sites for Class IV devices or where there are specific concerns about compliance. ANVISA has bilateral agreements with some foreign regulatory authorities (e.g., FDA, EU competent authorities) for information sharing on GMP inspection outcomes.

Official sources

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