MDSAP is a certification system established by the International Medical Device Regulatory Forum (IMDRF) for joint review for safety and quality management of medical device according to the international standards. It is jointly operated by 5 members of IMDRF: United States, Canada, Australia, Brazil, and Japan.

For a medical device manufacturer that has MDSAP certificate, only 5 countries: US (FDA), Canada (Health Canada), Japan (MHLW), Australia (TGA), and Brazil (ANVISA) are fully or partially exempted from certification review. This single review will save time and cost by complying with regulatory requirements of the selected country.

IMDRF is a council of regulating authorities established to integrate medical device regulations, and leading the level and direction of medical device regulation around the world since 2011. In 2017, Korea joined IMDRF as an 10^th official member, following the US, EU, Canada, Australia, Japan, China, Brazil, Russia, and Singapore.