Notice: Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality - Informing Canadians about medical device treatment options 

January 31, 2019

Our file number: 19-100575-552

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 all new Class III medical device licences (e.g. orthopedic implants or blood glucose monitors) starting January 31, 2019.

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. Previously, summaries of decisions were only published for the highest risk, new Class IV (e.g. pace makers or HIV test kits) medical devices.

With this Notice, Health Canada is announcing Phase III of the expansion of the RDS initiative for medical devices. Phase I 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. With the implementation of Phase III, Health Canada will now also publish RDSs for final positive decisions for new Class III medical device applications that are issued on or after January 31, 2019. This information will be made available to Canadians on Health Canada's Drug and Health Product Register. Further expansions of the RDS initiative for medical devices will be announced later in 2019.

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 higher-risk medical devices will further inform physician and patient decisions about treatment options and 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
Health Canada
1600 Scott Street, 6th floor
Ottawa, ON K1A 0K9

Telephone: 613-941-1248
Facsimile: 613-957-1483
Email: hc.opprs.enquiries-enquettes.bprse.sc@canada.ca

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