Health Canada Medical Device Single Audit Program (MDSAP) Advancements
In 2019, Health Canada has successfully completed the transition to the Medical Device Single Audit Program (MDSAP), replacing the Canadian Medical Devices Conformity Assessment System (CMDCAS). All manufacturers holding medical device licenses in Canada now participate in the program, which improves Health Canada's oversight of the medical devices sold in Canada, and ensures that the medical devices Canadians use meet higher quality standards.
In this webinar, Frédéric (Fred) Hamelin, Manager of the Quality Systems Section of the Medical Devices Directorate, will cover popular Medical Device Single Audit Program (MDSAP) topics for 2026, such as remote and hybrid audits, common audit pitfalls and findings, oversight of auditing organizations, MLMD and SaMD, and upcoming developments in the program. Fred will also answer questions on MDSAP from the audience.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].

Manager, Quality Systems Section, Bureau of Planning and Operations, Medical Devices Directorate, Health Canada
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