The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British Standards Institution (BSI). Health Canada had ordered these certification bodies to stop issuing ISO 13485 certificates, which had been granted under the purview of the Canadian Medical Devices Conformity Assessment System (CMDCAS), with any expiration dates beyond Dec. 31, 2018.

Health Canada told them that only ISO 13485 certificates issued by the Medical Device Single Audit Program (MDSAP) would be accepted by Health Canada after that date. As many medical device manufacturers were just getting brand new ISO 13485:2016 certificates, they were stunned when they saw their new certificates had been cut off at the knees. Instead of getting a certificate with a three-year expiration date as usual, the new certificates were set to expire in less than one year.

Considering that thousands of companies pay between $10,000 and $20,000 or more for their certificates, this behind-the-scenes demand by Health Canada could have amounted to tens of millions of dollars in lost value.

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