Resources / Medical Device Single Audit Program (MDSAP)

Many of my clients are beginning to investigate whether joining the Medical Device Single Audit Program (MDSAP) is a good fit for their organisation.

The program allows an MDSAP recognized Auditing Organization (AO) to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

Currently; the participating regulatory authorities are:

  • Therapeutic Goods Administration (TGA) of Australia
  • Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
  • Health Canada
  • Japan’s Ministry of Health, Labour and Welfare (MHLW) and the Japanese Pharmaceuticals and Medical Devices Agency
  • Food & Drug Administration (FDA) of the United States

The most important benefit of MDSAP is that a single audit is used instead of multiple separate audits or inspections by participating regulatory authorities or their representatives. Consequently, for many medical device manufacturers, MDSAP reduces the overall number of audits or inspections and optimizes the time and resources expended on audit activities.

For some clients who distribute medical devices to Canada, obtaining MDSAP certification is a must-have from the 1st of January 2019 as per Health Canada’s communications to the medical device industry.

For anyone researching into whether MDSAP is a worthwhile investment for your organisation, please find below some useful publicly available research resources:

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