In 2014, the Food and Drug Administration and regulatory agencies in Australia, Brazil, Canada and Japan embarked on a pilot called the Medical Device Single Audit Program (MDSAP). The goal was to develop a process that allows a single audit, or inspection to ensure that the medial device regulatory requirements for all five countries are satisfied, in an efficient and yet thorough manner.
On January 1, 2015 the MDSAP pilot reached a major milestone – manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. were invited to participate in the program. This summer, when Japan enters the MDSAP as a full member, the same invitation will be issued also to medical device manufacturers interested in marketing in Japan. FDA is now inviting medical device manufacturers to participate in the MDSAP Pilot.
Kim Trautman, Associate Director of International Affairs at the FDA’s Center for Devices and Radiological Health writes that under the pilot, audits will be conducted by recognized third-party organizations, and medical device regulators in the participating countries will be able to use these inspection reports when making their regulatory decisions.
Not only does this program reduce the participating regulators’ need to individually perform routine inspections; it allows them all to have the same reliable information about inspectional findings, Trautman explains in an FDA Voice blog.
Manufacturers, too, can benefit from the MDSAP pilot by cutting down on the number of regulatory audits they have to host, thereby minimizing manufacturing plant and personnel disruptions. This form of international and standardized oversight lessens the burden on manufacturers by bringing more consistency and transparency to the regulatory process.
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.
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. FDA has posted four new documents on the Pilot MDSAP which describes up to date information on how the five participating Regulatory Authorities will utilize the MDSAP Pilot Audit Reports to reduce audit burdens on manufacturers and leverage regulatory resources.