Although growing global interest in advanced medical technologies offers significant market potential for medical device manufacturers, the process of obtaining regulatory approval remains a complex one. This is especially true when it comes to pre- and post-market audits of a device manufacturer’s quality management system (QMS). Even in cases in which auditing requirements are substantially similar, independent regulatory authorities in key jurisdictions often decline to accept audit reports that address requirements of other regulators or regions. The absence of a mutual recognition scheme for QMS audits results in a significant added expense for device manufacturers selling in multiple economic areas as well as longer lead times for market acceptance.
Under the Medical Device Single Audit Program (MDSAP), a single audit performed by an authorized auditing organization is deemed sufficient to assess compliance with the QMS requirements of regulatory agencies in multiple major medical device markets, including the U.S., Canada, Japan, Brazil and Australia.
For the medical device industry, the MDSAP has transformed the approach used to conduct pre- and post-market QMS audits and significantly reduced the audit compliance challenges facing device manufacturers. Specific benefits of the MDSAP include:
- Harmonization of auditing requirements
- Broader acceptance of audit reports
- Reduced overall auditing time and expense
- Reduced time responding to findings
- Wider choice of third-party audit organizations
- More transparent and consistent oversight by regulators
This white paper provides an overview of the MDSAP and discusses how the single audit approach can benefit medical device manufacturers. Beginning with a brief history of the formation of the MDSAP, the paper then describes the audit process prescribed under the program and concludes with recommendations on how device manufacturers can take advantage of the MDSAP program.