Notice: Update: Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality - Informing Canadians about medical device treatment options
December 13, 2019
Our file number: 19-122746-266
Through its Action Plan on Medical Devices, Health Canada is committed to continuing to provide Canadians with more information on the medical devices they use. The Department is pleased to announce that it will begin publishing Regulatory Decision Summaries (RDSs) for amendments to Class III and IV medical device licences.
A Regulatory Decision Summary (RDS) explains Health Canada's decision to approve or reject the sale of certain medical devices and prescription pharmaceutical and biologic drug products in Canada. For medical devices, the RDSs provide information for patients and healthcare professionals, including a summary of the intended use of the device, and the reasons for Health Canada's decision to license the device.
Health Canada will now implement Phase IV of the RDS initiative for medical devices. Regulatory Decision Summaries will be published for final positive decisions issued on or after December 1, 2019 for:
- amendments to Class III medical devices (e.g. orthopedic implants or blood glucose monitors) and
- amendments to Class IV medical devices (e.g. pace makers or HIV test kits)
Phase I of the RDS initiative was launched in 2015, and included positive decisions for new Class IV medical device applications. Phase II launched in 2016 and expanded the scope to include negative decisions and withdrawals for new Class IV medical device applications. Phase III further expanded the scope in early 2019 to include final positive decisions for new Class III medical device applications.
Regulatory Decision Summaries are available to Canadians on Health Canada's Drug and Health Product Register.
Health Canada is committed to being transparent and open about its activities, and to making timely and useful information available to Canadians about health product submissions, including medical devices. The publication of RDSs for amendments to higher-risk medical devices will further inform physician and patient decisions about changes to treatment options. Canadians will now also have access to more information about the medical devices they use.
Any comments regarding this Notice should be directed to:
Office of Planning, Performance and Review Services (OPPRS)
Therapeutic Products Directorate
1600 Scott Street, 6th floor
Ottawa, ON K1A 0K9
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