The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the manufacturer would typically face when they sell their products in certain IMDRF member countries: the United States, Canada, Brazil, Australia, or Japan. The intention was to establish one medical device certification that would be accepted by multiple countries, thus reducing the costs and headaches associated with entertaining multiple audits from each country.

Until recently, all participating countries had made MDSAP optional. But, in a move that may have unintended consequences, on Dec. 4, 2015, Health Canada announced that MDSAP will be required.

Understanding the problem

Since January 2014 the number of MDSAP audits has fallen well short of the 330 that IMDRF needed to validate MDSAP as a working program. As of August 2015, only 45 companies had signed up for MDSAP audits, and most of them had not been visited. There is, I believe, a reason why so few companies have chosen to participate in MDSAP. Ironically, it’s too much transparency.

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