Health Canada releases Action Plan on Medical Devices

Health Canada has launched an Action Plan on Medical Devices. Health Canada say the plan:

“lays out a three-part strategy, which will be achieved through improving how devices get on the market; strengthening monitoring and follow-up of devices once they are being used by Canadians; and providing more information to Canadians about the medical devices they use. Collaboration with provinces and territories, and other health care system partners will be fundamental to delivering results.”

The three parts of the plan are:

1: Improve how devices get on the market

This section focusses on increasing research into medical devices, particularly around how they are tested. A review of the evidence required for medical devices is also proposed by the plan.

2: Strengthen monitoring and follow-up

The Canadian Medical Devices Sentinel Network (CMDSNet) will be expanded from its current 17 organisations (representing more than 260 hospitals and facilities across the country). Furthermore:

“Health Canada will also be able to compel manufacturers to provide information to address a health risk or to monitor experience with their product. Manufacturers will be required to inform Health Canada within 72 hours if selected foreign regulatory agencies issue warnings about serious risks related to their medical device. Manufacturers will also be required to submit information regarding label changes or license suspensions.”

Enforcement powers will be enhanced to give Health Canada more weight with manufacturers.

3: Provide more information to Canadians

Access to clinical data about medical devices will be made more available to the public, as will information on device approvals and medical device incident data.

Read the full plan here.

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Published on 21. December 2018 in News