GMP Equivalence — Accepting ISO 13485 for Foreign Manufacturers
For imported medical devices, ANVISA accepts evidence of foreign manufacturer GMP compliance in the form of:
| Evidence type | Accepted for |
|---|---|
| ISO 13485 certificate from an accredited CB | Class II, III, and generally IV devices |
| EU notified body certificate (MDR) | Class II, III and generally IV |
| FDA QMSR compliance evidence (510(k)/PMA) | Class III and IV |
| CBPF from ANVISA or state VISA | Always accepted (Brazil GMP certificate) |
ANVISA may conduct its own inspection of a foreign manufacturer's facility for Class IV devices or where specific concerns exist. Brazil has bilateral agreements with some foreign regulatory authorities for GMP information sharing.
The ISO 13485 certificate must:
- Be current (not expired);
- Cover the specific site and device types being imported; and
- Be issued by an accredited certification body (accredited under IAF MLA for ISO 13485).
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.