The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell their products in Canada. This mandate could have consequences for Canadian citizens.

What is the Medical Device Single Audit Program?

Is MDSAP one certification accepted by all? No, however it is accepted by five countries: the United States, Canada, Brazil, Australia, and Japan. 

What medical device company that sells internationally wouldn’t want a yearly one-and-done audit that satisfies the regulatory requirements of those five countries? Within the medical device community, where audits are strict and often expensive, the ability to go through a single quality management system (QMS) audit and have those audit results accepted by five countries would theoretically save time and money compared to dealing with each country’s regulations individually. That was the intended goal behind the Medical Device Single Audit Program (MDSAP). However, as is the case with many plans, the unintended consequences may hurt not just the medical device companies it was supposed to help, but in the end may harm consumers.

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