The Medical Device Single Audit Program Pilot consortium Regulatory Authority Council is inviting medical device manufacturers to participate in the MDSAP Pilot.
Under this pilot, manufacturers that market medical devices and in vitro diagnostics in Australia, Brazil, Canada, and the U.S. can volunteer to be inspected by a MDSAP-recognized third-party organization.
Medical device regulators in the participating countries will be able to use these inspection reports when making their regulatory decisions. This will decrease the number of regulatory audits manufacturers have to host, thereby minimizing manufacturing plant and personnel disruptions.
This summer manufacturers that market medical devices and in vitro diagnostic in Japan will also be invited to participate in the pilot.
The manufacturers that participate in the process during the pilot will help shape the policies and procedures for the operational program scheduled to begin in 2017.
Kim Trautman is Associate Director of International Affairs at the FDA’s Center for Devices and Radiological Health wrote about the program in a recent blog post on the FDA Voice blog, where imformation on how to participate may also be found.