Webinar Description:
The Medical Devices Inspection Program of the Regulatory Operations and Enforcement Branch inspects domestic and foreign manufacturers of Class I medical devices and importers and distributors of Class I–IV medical devices.
The presentation provides an overview of the MDI program including:
- Risk-based inspection approach
- Foreign inspection strategy
- How to prepare for an inspection
- Common observations
About the Speakers:
Erin Skuce – Director, Medical Devices Compliance Program, Medical Devices Clinical Compliance Directorate, Regulatory Operations & Enforcement Branch
As Director, Erin oversees post-market compliance and enforcement, recall reporting, inspections, and medical devices establishments licensing. Erin holds an Honours Bachelor of Biomedical Science from the University of Guelph. With over 22 years in public service, she has experience in policy, project and program management, including roles in the Office of Sustainable Development, the Canadian Strategy for Cancer Control, and the Good Guidance Practices and Good Review Practices Initiatives. She has held various inspection and management roles in the Controlled Substances, Consumer Product Safety, and Cannabis inspection programs. Before joining the MDCP as Director in 2024, she was the Director of the Strategic Program Support Division within the Cannabis Directorate and the National Director of the Consumer Product Safety Inspection Program.
Ada Lai – Regulatory Compliance and Enforcement Specialist, Medical Devices Inspection Program, Medical Devices Clinical Compliance Directorate, Regulatory Operations & Enforcement Branch
Ada Lai is the Compliance and Enforcement Specialist of the Medical Devices Inspection Program at Health Canada. She works in the National Manager's Office that supports teams across Canada that conduct post-market compliance and enforcement activities on manufacturers, importers, and/or distributers of medical devices. She has been working in this program for the past 17 years, in both inspector and program advisory roles.
Have Questions?
Be part of the conversation. Submit your questions in advance to info@diac.ca by October 8, 2025. Please use the subject line "Question for Inspections".
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 14, 2025.
