Human factors engineering (HFE) efforts are becoming a regulatory necessity for medical device companies in markets around the world. Combination product manufacturers face some unique...
In Brief: Brazil’s ANVISA Recognizes Second MDSAP Auditor
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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.
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