Foreign and local medical device manufacturers are now required to be inspected and be in compliance with the Brazilian Good Manufacturing Practices requirements prior to the submission of their devices for registration with ANVISA, the Brazilian authority in charge of the medical devices and IVDs clearance. The GMP certificates must be submitted together with the registration requirements for these products.

The abovementioned condition is applicable to:
(a) Equipment and materials in the two highest risk classes, III and IV.
(b) In vitro diagnostics products in the highest risk classes, II, III and IIIa.

Most class I and II devices are exempt from the B-GMP requirements because in the past ANVISA had lack of resources available to audit manufacturers in a timely manner. However, now that the first dossiers submitted back in May 2010 are actually being evaluated, we are learning that different criteria exist within ANVISA. Some inspectors accept the dossiers without the B-GMP while others do not and annul the proceedings. Based on our experience and contacts in the industry, we feel that Class I and II devices should be evaluated on a case by case basis since the requirement for B-GMP certificates for these classifications is ambiguous at the moment.

In view of this uncertainty, we advise our clients who manufacture class I and II devices to take a conservative approach and either request B-GMP inspection or understand that there are chances that their registration process may be rejected (January 2011).

For more information about this process and for assistance with the preparation of your B-GMP inspection, please submit your inquiry or choose to consult our online experts right now.