EMERGO SUMMARY OF KEY POINTS:

• Brazilian regulators now allow domestic manufacturers to apply for quality system certification under the Medical Device Single Audit Program (MDSAP).
• Previously, ANVISA’s position was to recognize MDSAP certification only for foreign manufacturers.

Brazilian medical device market regulator ANVISA has officially extended applicability of the Medical Device Single Audit Program (MDSAP) to domestic manufacturers as well as other companies based in South America.

According to RDC 217.2018 (link in Portuguese), the MDSAP good manufacturing practice certification route is now open to medical device manufacturers based in Brazil, as well as to manufacturers based in South American countries belonging to the MERCOSUL trade group: Argentina, Paraguay and Uruguay.

Prior to RDC 217.2018, Brazil’s MDSAP certification route had only been available to foreign manufacturers registering with ANVISA. Now, domestic ANVISA registrants may also leverage MDSAP quality system certification for access to other participating markets—the US, Canada, Australia and Japan.

Related MDSAP and Brazilian medical device regulatory information:

• Brazil ANVISA medical device registration consulting
• Brazil GMP (BGMP) quality system compliance consulting
• On-site MDSAP training for medical device companies
• MDSAP compliance transition support
• Whitepaper: MDSAP certification pathway
• Whitepaper: Brazil ANVISA medical device registration