MDSAP Framework

The MDSAP (Medical Device Single Audit Program) is an international quality management systems evaluation programme for medical device manufacturers that sell their products in Australia, Brazil, Canada, the United States, and Japan.
Objective: to reduce the number of audits in each of these five markets with one sole audit.

The MDSAP responds to the requirements of the quality management systems below:

  • Medical Devices – Quality Management Systems – Requirements for regulatory purposes (ISO 13485:2016)
  • Compliance evaluation procedures for Australian Therapeutics Goods (Medical Devices) Regulations (TG(MD)R Sch3)
  • Brazilian manufacturing good practices (RDC ANVISA 16/2013)
  • Japanese QMS Ordinance (MHLW MO 169)
  • Quality System Regulation (21 CFR Part 820)

The MDSAP’s requirements are those of ISO 13485 completed by the specific requirements of the five countries concerned by this programme.

From 1 January 2019, only MDSAP-certified manufacturers will be able to sell their medical devices in Canada..

  • Australia: The Therapeutics Goods Administration TGA will request a MDSAP audit report in the frame of proof evaluated for compliance with market authorisations for medical devices, unless the medical device is otherwise excluded or exempt from these requirements, or if the policies in force restrict use of the MDSAP’s audit reports.
  • Brazil: The Brazilian national agency for health surveillance, ANVISA, will use the results of the programme, including in the report, to constitute a major contribution to evaluation procedures prior to and after ANVISA’s release on the market, providing, if necessary, the key information required to support the regulatory technical evaluation of these points.
  • United States: The US Food and Drug Administration’s Center for Devices and Radiological Health The FDA will accept the MDSAP’s audit reports as a substitute for the FDA’s routine inspections.

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