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Session 2 Track A: Health Canada Activities in the Medical Devices Area During the COVID-19 Pandemic
Session Chair(s)
Patrick Fandja, MBA, MS
Director, Bureau of Biologics, Radiopharmaceuticals and Self-care products
Health Canada, Canada
At the onset of the COVID-19 pandemic, Health Canada introduced a number of innovative and agile regulatory measures to facilitate access of medical devices needed for COVID -19, to Canadians and healthcare workers. These measures cover the lifecycle of medical devices; clinical trials for COVID-19, In Vitro diagnostic testing devices for COVID-19, post-market surveillance, Medical Device Establishment Licences and Inspection. The objective of this session is to provide an overview of Health Canada’s activities in the medical devices area during the COVID-19 pandemic.
Learning Objective : At the conclusion of this session, participants should be able to:
- Outline Health Canada’s activities in Clinical Trials and Post-market surveillance of COVID-19 devices
- Gain awareness of COVID-19 testing technologies approved by Health Canada
- Outline Health Canada’s activities in Medical Establishment Licences and Inspection during COVID-19 Pandemic
Speaker(s)
Clinical Trials and Post-market Surveillance of COVID-19 Medical Devices
Tanya Ramsamy, PHD
Health Canada, Canada
Executive Director, Medical Device Directorate
COVID-19 Testing Devices
Christine Leckie
Health Canada, Canada
A/Executive Director, Medical Device Directorate
Medical Devices Establishment Licenses and Inspections
Marie Odile N. Gomis, MS
Health Canada, Canada
Manager, Regulatory Operations and Enforcement Branch