Jan 25, 2016
Brazilian medical device market regulator ANVISA has named a second firm, TÜV SÜD America, as an accredited audit organization under the international Medical Device Single Audit Program (MDSAP).
ANVISA has already recognized BSI as an accredited auditor under MDSAP. Now, both BSI and TÜV SÜD America may conduct audits in accordance with Brazilian regulators’ MDSAP implementation program.
The TÜV SÜD America recognition is valid until December 31, 2016, after which ANVISA may revoke or renew the MDSAP auditor accreditation.
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.
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).