Health Canada to Provide Assistance for SMEs to Meet MDSAP Deadline

Health Canada is sticking to its compliance deadline of Jan. 1, 2019 for devicemakers selling products in Canada to transition to the Medical Device Single Audit Program but is making adjustments to help small to medium-sized enterprises comply.

Holders of Class II, III and IV device licenses are expected to complete the transition before the deadline, and MDSAP certificates will be required to obtain or amend licenses.

However, the agency is shortening the audit or reducing fees for SMEs, according to Frédéric Hamelin, manager of the Quality Systems Section of the Medical Devices Bureau at Health Canada.