MDSAP Program: Principles, implementation and advantages

The Medical Device Single Audit Program (MDSAP) initiative started in 2012 and has been fully operational in 2017. Since then, MDSAP has been adopted by several countries and the interest from regulators and manufacturers across the globe continues to grow. Today, approximately 7000 medical device manufacturer sites have enlisted in the program. Therefore, it is reasonable to infer that there is an increasing trend in applications due to the streamlined and clear approach to regulatory compliance, allowing manufacturers to demonstrate compliance with the requirements of multiple major medical device markets through a single audit process.

With MDSAP certification, medical device manufacturers can undergo a single audit, entrusted to authorized certification bodies named (Auditing Organizations (AO)), that will be considered when selling/registering devices in the 5 different markets. MDSAP program is based on QMS requirements according to ISO 13485:2016 with consideration of regulatory requirements related to each of the 5 participating countries. The application of a country’s regulations requirement depends on where the manufacturer sells or intends to sell its devices.

As of today, the countries which are using the MDSAP reports and certificates are Australia, Brazil, Canada, Japan, and the United States of America (USA)

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