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The Basics: Understanding the Medical Device Single Audit Program

FDA and regulatory counterparts in several countries introduced the Medical Device Single Audit Program (MDSAP) Pilot, an international effort to harmonize the inspection and auditing of medical device manufacturers in a single annual audit to be conducted by third-party certification body auditors. MDSAP procedures refer to these certification bodies as “auditing organizations.” The program is the result of efforts by the International Medical Device Regulators Forum (IMDRF), and satisfies the requirements of four regulatory bodies:

  • U.S. Food & Drug Administration (FDA)
  • Brazilian National Health Surveillance Agency, Agência Nacional de Vigilância Sanitária (ANVISA)
  • Health Canada (HC)
  • Australian Therapeutic Goods Administration (TGA)

Japan will become the fifth, full member of the pilot program this summer. Several of the European Notified Bodies are actually conducting the MDSAP audits, and it is expected that Europe will also join the MDSAP when the program is fully implemented in 2017.

FDA will accept the MDSAP audit reports in lieu of routine Level 1 and Level 2 inspections. However, MDSAP audit reports will not replace “For Cause” FDA inspections or Level 3 follow-up inspections by FDA. MDSAP audits will not replace pre-clearance/pre-approval inspections for 510(k) or PMA submissions, either.

ANVISA will use MDSAP audit reports as part of the pre- and postmarket assessment processes. ANVISA will also accept MDSAP audits in lieu of the initial ANVISA audit. This is critical, because there is an average backlog of three years for initial inspections.

Health Canada
HC intends to replace the existing CMDCAS certification program with MDSAP as the method of verifying that Health Canada’s quality management system requirements is met. This is another reason why only registrars recognized by Health Canada were invited to apply for participation in the MDSAP Pilot.

Australian TGA
Australia’s TGA will use MDSAP audit reports as an input to decisions for issuing market authorization, unless the device is excluded or exempted, or current policy prohibits the use of MDSAP audit reports. In addition, the Australian TGA recently became HC’s 15th recognized registrar.

Japan’s Ministry of Health, Labor & Welfare (MHLW)
Japan’s MHLW and Material Authorization Holders (MAHs) perform onsite inspections of manufacturers for compliance with the Japanese Pharmaceutical Affairs Law (JPAL). Changes to JPAL were approved in November 2013 and launched in November 2014. As part of the changes, the MHLW is allowing Certification Bodies to audit additional device classifications. Also, MHLW is now an official observer and active participant in the MDSAP Pilot. MHLW becomes a full member in the summer of 2015. 

Don't miss Robert Packard's presentations at OMTEC 2015.
Presentations include:

2016 European Medical Device Regulations: Significant Changes for Importers and Distributors and
2016 European Medical Device Regulations: Preparing for the Spinal Implant Reclassification