According to an FDA blog post, the FDA and regulatory agencies in Australia, Brazil, Canada, and Japan embarked in 2014 on a pilot called the Medical Device Single Audit Program (MDSAP). Its goal is to develop a process that allows a single audit, or inspection to ensure the medical device regulatory requirements for all five countries are satisfied, in a thorough and efficient manner.
On January 1, 2015, manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the US 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.
Under this 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.
