The MDSAP (Medical Device Single Audit Program) certification can finally be requested by manufacturers based in Brazil or in other countries belonging to the MERCOSUR single market group (Argentina, Paraguay and Uruguay).

Although the MDSAP is an audit program whose members are the USA, Canada, Brazil, Japan and Australia, until January only foreign manufacturers registered with ANVISA could request such certification, thus excluding local ones.

It is therefore an important novelty for the Brazilian market. In fact, with RDC 217/2018 issued by the Brazilian Regulatory Authority (ANVISA) in February 2018, local manufacturers have the possibility to request the Quality System certification in compliance with the MDSAP requirements.

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