Launch of the Medical Device Single Audit Program (MDSAP) Pilot

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Launch of the Medical Device Single Audit Program (MDSAP) Pilot

The Australian Therapeutic Goods Administration (TGA), Brazil’s ANVISA, Health Canada and the US Food and Drug Administration announced the launch of the MDSAP pilot from January 2014,  

Upon implementation of the MDSAP program, the audit of a medical device manufacturer’s quality system in any one of the four participating countries will meet regulatory requirements of all four countries—a significant move that could ease medical device company’s paths to market in these regions.

The development of the MDSAP includes the use of third party auditors, much like some current regulatory audit programs, as well as regulatory inspectorates. Recognizing the increasingly global nature and number of medical device manufacturers, the use of third party auditors in addition to Regulatory Authority Inspectorates, allows greater coverage in auditing manufacturers as opposed to relying solely on the government resources of individual countries. The government resources can then be focused on high risk or problematic medical devices, manufacturers that are not in compliance with the regulations, and oversight of the third party auditing organizations.