The Medical Device Single Audit Program (MDSAP) is an initiative started in 2012. This young program has been accepted by several countries. The growing company adoption demonstrates the interest for companies and regulators across the world.

With the MDSAP certification, medical device manufacturers can undertake a single audit that will be considered when selling devices in different markets. MDSAP program is based on  QMS requirements according to ISO 13485 with consideration of regulatory requirements related to each of the participating countries. The application of country’s regulations requirement depends where the manufacturer sells or wants to sell devices.

As of today, the countries which are using the MDSAP reports and certificates are Australia, Brazil, Canada, Japan, and the USA.




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