ANVISA Formally Recognizes MDSAP Program for Foreign Quality System Audits
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.
The new resolution (link in Portuguese) states that any auditing organization that complies with requirements of the Medical Device Single Audit Program (MDSAP) will be recognized by ANVISA and published in the Brazilian government’s official gazette.
By officially recognizing MDSAP, Brazilian regulators may now proceed with developing and providing specific criteria and requirements in order to accept quality system audit reports from accredited US, Australian or Canadian auditors or inspectors.
For foreign manufacturers hesitant to enter the Brazilian market because of Brazilian Good Manufacturing Practice (BGMP) requirements, ANVISA’s formal recognition of MDSAP shows that the regulator is serious about providing alternate quality system compliance options.