Feb 27, 2018
EMERGO SUMMARY OF KEY POINTS:
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.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: