History

In 2012, the International Medical Device Regulators Forum (IMDRF) identified a work group to develop specific documents for advancing an MDSAP. A Statement of Cooperation was subsequently signed in November 2012 by Australia, Brazil, Canada and the United States, with the goal of the MDSAP to provide for more effective, efficient and less burdensome regulatory oversight of the QMS of medical device manufacturers.  

In June 2015, Japan's regulatory agencies MHLW and PMDA became a recognized MDSAP RAC Member. Since commencement, the WHO, the EU and the United Kingdom’s MHRA have also participated in MDSAP as Official Observers. 

The MDSAP Pilot commenced in January 2014. After its completion in 2016, the MDSAP Final Pilot Report provided confirmation that a regulatory audit of a medical device manufacturer conducted by an MDSAP recognized AO can fulfill the needs of participating regulatory jurisdictions. 

In March 2016, the MDSAP moved from a pilot program into a fully operational program. The MDSAP program has grown significantly since its commencement, now including around 7000 certified medical device manufacturers.   

Since 2023, the MDSAP RAC has embarked on enhancement projects designed to increase the capacity and for future sustainability and performance of the program. When available, further information on these enhancements will be notified under News.  

Further information on how to participate in MDSAP as a member or a recognized AO is available under MDSAP Membership and Auditing Organizations.