Medical Device Single Audit Program

The Therapeutics Goods Administration (TGA) uses an MDSAP audit report as part of the evidence that it has assessed for compliance with medical device market authorization requirements, unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports.

The Brazilian National Health Surveillance Agency ANVISA utilizes the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and postmarket assessment procedures. It provides, when applicable, key information that is expected to support regulatory technical evaluation on these issues.

Health Canada Health Canada (HC) will ONLY accept MDSAP for manufacturers who market their devices in Canada. Therefore, manufacturers wishing to place a product on the market in Canada need to have MDSAP Certification issued by an AO.

The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) will utilize these audit reports in both pre-market and periodical post-market audits under regulations in Japan.

U.S. Food and Drug Administration’s Center for Devices and Radiological Health FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “For Cause” or “Compliance Follow-up” by FDA will not be affected by this program. Moreover, the MDSAP program would not apply to any necessary pre-approval or post-approval inspections for Pre-Market Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)
(5)) concerning the classification of a device.