GMP Equivalence — Accepting ISO 13485 for Foreign Manufacturers
For imported medical III or devices, high-risk device types, compliance Such inspections are typically announced and coordinated through bilateral regulatory agreements or directly with the manufacturing facility., 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 issued under the Medical Device Regulation (MDR) 2017/745 or the former Medical Devices Directive (MDD) 93/42/EEC | 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 III or IV devices, high-risk device types, or where specific compliance concerns exist. Such inspections are typically announced and coordinated through bilateral regulatory agreements or directly with the manufacturing facility. 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).
Verify all information against official ANVISA sources before making regulatory decisions.