Canada – Health Canada: MDSAP Could Force Some Manufacturers Out

With the approaching deadline for those in Canada to comply with the Medical Device Single Audit Program (MDSAP), Health Canada issued a notice to recognize that some device makers may be cancelling their licenses to avoid dealing with the new requirements.

“It is anticipated that some manufacturers, instead of conforming to the new MDSAP requirements, may be cancelling their medical device licences and discontinuing the sale of their products as early as November 1, 2018,” Health Canada said.

Thnotice, quietly issued late last month, puts forth what industry has been expecting to come from the new requirements on all manufacturers of Class II, III and IV medical devices.

Small- to medium-sized device manufacturers, in particular, that are already on the Canada market have been scrambling to schedule these audits and obtain MDSAP certificates ahead of 1 January 2019, as previously reported by Focus. Others, including startups, have reportedly been in a “wait-and-see” mode on if Health Canada will ease requirements.

With the goal of addressing concerns over the delays many have experienced between when an audit is conducted and the certificate is subsequently issued, the last action Health Canadtook was in April. This update informed of the regulator’s decision not to take enforcement actions against manufacturers that have yet to obtain MDSAP certificates as of 31 December 2018…