Following the Australian Therapeutic Goods Administration’s recent news that Australia, Brazil, Canada and the US will launch a pilot for the Medical Device Single Audit Program (MDSAP) for medical devices in January 2014, The US Food and Drug Administration has provided additional information on its planned participation in the pilot.

During the MDSAP pilot, the FDA will accept MDSAP audit reports as substitutes for the agency’s own routine 21 CFR Part 820 quality system inspections. Other participating regulators will treat MDSAP reports as follows:

• Australia: the TGA will use MDSAP audit reports to help determine compliance with Australian medical device registration requirements.
• Brazil: ANVISA will use MDSAP audit reports and other components of the program in its pre- and post-market medical device evaluations.
• Canada: Health Canada will use MDSAP reports as part of its Canadian Medical Device Conformity Assessment System (CMDCAS). Canadian medical device regulators plan to use MDSAP as the primary method for determining quality management system compliance after the pilot program ends.

In the US, regulators will only accept MDSAP audit reports in lieu of routine quality system inspections—any “for cause” or “compliance follow-up” inspections, as well as pre- and post-approval inspections for Premarket Approval (PMA) applications, do not qualify for the MDSAP.

Although Japan is not officially participating in the MDSAP pilot, both the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) are acting as observers. This suggests more involvement by Japanese medical device regulators in the MDSAP further down the line.

Stewart Eisenhart