Dec 21, 2015

Brazilian medical device market regulator ANVISA has formally recognized BSI Group (the British Standards Institute) as an accredited auditing organization under the international Medical Device Single Audit Program (MDSAP).

The BSI announcement comes ahead of AVISA’s first expected Brazilian Good Manufacturing Practice (BGMP) certificate to be issued under MDSAP in the final days of 2015.

Although ANVISA must still issue a Technical Note providing full details, Emergo consultants in Brazil report that based on meetings with the regulator, the agency will not review or approve MDSAP audit reports issued by other participating regulators (the US FDA, Australian Therapeutic Goods Administration, Health Canada and/or Japanese PMDA), but only check registrants’ MSDAP Certificates to verify that such audits were successful. However, MDSAP will not exempt companies from paying BGMP fees.

Over time, ANVISA is expected to recognize more organizations besides BSI as accredited MDSAP audit organizations. For medical device manufacturers willing to participate in the MDSAP in order to commercialize in Brazil, these developments mean that such firms will have easier market access, and more efficiently meet BGMP requirements in order to register their devices with ANVISA.

Emergo will continue to monitor MDSAP implementation progress in Brazil as well as the program’s other participating markets to provide further updates.


  • Stewart Eisenhart