Webinar Description:
The Medical Devices Establishment Licensing (MDEL) Unit of the Regulatory Operations and Enforcement Branch reviews license applications, amendments and notifications, and issues licenses to companies that import and/or distribute medical devices. The presentation provides a brief overview of the MDEL application process including:
- Overview of the different types of MDEL applications
- Recent MDEL updates and changes
- Review of license applications-common mistakes and guidance for efficient submission
- Overview of the Annual License Review (ALR) non-responder process
Speakers:
Marie-Odile Gomis, Manager, Medical Devices Establishment Licence Unit, Medical Devices Clinical Compliance Directorate, Regulatory Operations & Enforcement Branch
Marie Odile N Gomis is a national manager at Health Canada's Regulatory Operations and Enforcement Branch, where she oversees the Medical Devices Establishment Licence program. As a federal regulator with prior experience in the pharmaceutical industry, she worked on enforcing compliance across drugs, natural health products, cannabis-related activities and medical devices. In her current role, she leads continuous process improvements when it comes to licensing, prioritizing compliance and efficiency while fostering stakeholder collaboration within the regulatory framework. Her academic journey includes earning a B.Sc. in Biotechnology and Molecular Biology and a M.Sc. from McGill University.
Barbara Morgan - Senior Regulatory Policy and Risk Management Advisor, Medical Devices Establishment Licence Unit, Medical Devices Clinical Compliance Directorate, Regulatory Operations & Enforcement Branch
Barbara Morgan is a Senior Regulatory Policy and Risk Management Advisor with the Medical Devices Compliance Program’s Establishment Licence Unit. She holds a Bachelor of Science in Chemistry, with extensive experience in the interpretation and implementation of health product regulations. Before joining Health Canada, Barbara held roles in industry as a lead in quality systems management, continuous improvement, and compliance. She is enthusiastic about innovation and the adoption of new technology and supports in developing the organization’s knowledge base as an active trainee and trainer.
Have Questions?
Be part of the conversation. Submit your questions in advance to info@diac.ca by October 22, 2025. Please use the subject line "Question for Establishment Licensing".
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 28, 2025.
