Feb 3, 2017
EMERGO SUMMARY OF KEY POINTS:
Brazilian medical device market regulator ANVISA has added two more firms to its list of accredited inspectorsfor the Medical Device Single Audit Program (MDSAP).
The new additions are DQS Medizinprodukte GmbH of Germany and DEKRA Certification B.V. of The Netherlands (links in Portuguese). Accredited through December 31, 2018, the two organizations are now authorized to perform Brazilian Good Manufacturing Practice (BGMP) medical device quality system inspections recognized by ANVISA and other MDSAP participating regulators.
Full MDSAP implementation among participating regulators in the US, Canada, Brazil, Australia and Japan was slated for January 2017. Emergo will provide updates and analysis on implementation efforts among these participants as we learn them.
Brazilian medical device market regulator ANVISA has formally recognized a program whereby the agency will accept quality system certifications from US, Canadian and/or Australian regulators in order to register devices from foreign manufacturers for sale in the country.