Pre-Market Screening Requirements, and Medical Device Single Audit Program (MDSAP)

Webinar Description:

Join us for this informative DIAC webinar focused on key regulatory updates for the medical device industry.

The Director of the Medical Devices Directorate’s Bureau of Licensing Services will provide practical tips for submitting successful medical device license applications and answer questions from attendees. 

In addition, the session will highlight recent developments in the Medical Device Single Audit Program (MDSAP) and its alignment with ISO standards.

About the Speakers:

Colin’s academic background is in the area of cellular and molecular medicine with a specific focus on cancer-based retinoid therapies (M.Sc). Colin has been a medical device regulator with Health Canada for 16 years. Colin and his team are responsible for assisting stakeholders in understanding their regulatory obligations by helping them navigate through Health Canada’s medical device legislation, regulations and guidelines. Colin also contributes to the development of policies, guidance documents and tools that help establish a more transparent and efficient regulatory system in Canada.

Frédéric Hamelin is the Manager of the Quality Systems Section in the Bureau of Planning and Operations of the Medical Devices Directorate (MDD). He has a long history of international collaboration and harmonization dating back to his membership in the Global Harmonization Task Force (GHTF) Study Group 4 starting in 2006, his participation in the development of ISO 13485:2016, and his pivotal contribution to the development of the Medical Device Single Audit Program (MDSAP). Fred is the current Chair of the Canadian Mirror Committee to ISO Technical Committee 210 and CSA’s Z289 technical committee on Quality Management and General Aspects for Medical Devices.  He is currently a subject matter expert, assessment team leader, and assessment program manager representing Canada in the MDSAP Consortium. Prior to joining MDD in 2002, Frédéric worked in sensing material research at the National Research Council and in process integration and optimization in industry. He holds a degree in Chemical Engineering.

Have Questions?
Be part of the conversation. Submit your questions in advance to info@diac.ca by October 1, 2025. Please use the subject line "Question for Pre-Market Screening Requirements, and MDSAP".

Registration Fee:
Free for DIAC members | $99 for non-members (fee credited if you join DIAC).

Registration Deadline:
Closes at 1:00 PM on October 7, 2025.