FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Health Canada Makes Further Concessions to MDSAP Transition Plan

Nov. 7, 2018
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Health Canada said it wants to help devicemakers make the transition to the Medical Device Single Audit program and the agency has urged manufacturers to renew their licenses immediately, irrespective of their MDSAP status.

Canadian manufacturers need to renew annual licenses before Nov. 1, and Frederic Hamelin, manager of Quality Systems in Health Canada’s Medical Devices Bureau, urged manufacturers to do this now as the MDSAP process is separate.

Hamelin noted the agency has made a number of concessions to allow devicemakers more time to comply during the MDSAP transition. In May, the agency reduced audit requirements for smaller companies with lower-risk products.

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