Medical Device Single Audit Program (MDSAP)

Medical Device Single Audit ProgramThe Medical Device Single Audit Program (MDSAP) is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements.  

Five of the RAs (Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW) have been running a three year MDSAP pilot. Health Canada has announced that as of 1 January 2019, they will terminate their current CMDCAS program and only accept MDSAP certificates.

The pilot ends December 2016 and the formal program begins January 2017. 

BSI is a designated AO. We are fully supporting the MDSAP pilot and have been conducting these audits since September 2014. We’ve experienced increased interest and sign ups by manufacturers during 2015 with momentum increasing in 2016.  Feedback about the benefits has been overwhelmingly positive.

FDA guidance on MDSAP can be below:

MDSAP Guidance Documents

View a comprehensive explanatory webinar

FDA MDSAP Frequently Asked Questions

Which Regulatory Authorities are part of the initiative?

There has been significant progress with the Medical Device Single Audit Program (MDSAP) pilot. The five RA’s in the MDSAP pilot have made the following statements on they intend to utilize MDSAP reports:

  • Australia: The Therapeutics Goods Administration TGA will use an MDSAP audit report as part of the evidence that is 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.
  • Brazil: The Brazilian National Health Surveillance Agency ANVISA will utilize the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support regulatory technical evaluation on these issues.
  • Canada: Health Canada HC will use a MDSAP audit as part of their Canadian Medical Device Conformity Assessment System (CMDCAS) certification program. Upon the successful conclusion of the pilot, Health Canada's intent is to implement the Medical Device Single Audit Program, as the mechanism to achieve regulatory compliance for quality management system requirements in Canada.
  • United States: 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, this MDSAP program would not apply to any necessary pre-approval or post approval inspections for Premarket 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.
  • Japan: The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) will utilize these audit reports in both premarket and periodical post market audit under regulations in Japan. Japan officially joined the pilot in June 2015.