Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer’s QMS which satisfies the requirements of multiple regulatory jurisdictions. The program uses ISO 13485:2016 as the common framework, adding country-specific regulatory requirements, e.g. as related to market authorization and registration, adverse event reporting etc. MDSAP does not take away from any product approval or registration requirements in the individual countries.
As part of the program, regardless of the outcome, the regulators of all participating jurisdictions can review the reports. Additionally, a database will be set up for these reports, so any of the participating countries can review reports associated with an organization or medical device, as well as trending non-conformities.
MDSAP is a way that medical device manufacturers can be audited once for compliance to regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.