I have written previously about the Medical Device Single Audit Program (MDSAP) created by the International Medical Device Regulators Forum (IMDRF). MDSAP is viewed as a single audit covering the United States, Canada, Brazil, Australia, and Japan. The intent was to establish one medical-device certification that would be accepted by multiple countries. It is actually much bigger and deeper than that.

The pilot phase for the program began in January 2014 and finished in December 2016. A report on the outcome from the pilot program was recently published, including data on the number of manufacturers that have signed up through the end of June 2017. The report indicates a number of successes across many of its proof-of-concept requirements, but a key disappointment remains: Only 10 percent of 3,300 Canadian medical-device manufacturers that were solicited to participate actually signed up, even under some pressure from Health Canada’s announcement that MDSAP certification would be mandatory to sell medical devices in Canada by Feb. 1, 2019.

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