ANVISA adds LNE G-Med to list of MDSAP auditors

By Stewart Eisenhart, Emergo Group

Brazilian medical device market regulators have recognized Laboratoire National de Métrologie et d’Essais’s G-MED Certification Division (LNE G-Med) as an accredited auditor under the Medical Device Single Audit Program (MDSAP).

With this latest addition, ANVISA has now recognized four auditors for participation in Brazil’s MDSAP effort: LNE G-MED, BSI Group America, TÜV SÜD America and Intertek Testing Services NA. LNE G-MED’s recognition will remain valid until December 31, 2016.

The goal of MDSAP is to allow recognition of medical device quality system audits and inspections across all participating countries: the US, Australia, Brazil, Canada and Japan.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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