(ISO 13485 / CMDCAS & MDSAP)
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Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program was developed by a group of medical device regulators to allow recognized third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485 and their respective regulatory requirements.
The regulatory authorities that are currently participating in the MDSAP Pilot Program are:
- Australia - TGA
- Brazil - ANVISA
- Canada - Health Canada
- U.S. - FDA
- Ministry of Health, Labour and Welfare (MHLW) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)
How will regulatory authorities utilize MDSAP audit 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.
Japan: MHLW and PMDA will utilize these audit reports in both premarket and periodical post market audit under regulations in Japan. Undergoing the MDSAP Pilot audits is expected .to reduce some burden on Japanese regulatory processes.
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.”
Note: The European Union, China and Russia are members of the IMDRF Management Committee but are not participating in the pilot program at this time.