Strengthening Post-market Surveillance and Risk Management of Medical Devices in Canada

Author: Bhavesh Patel, C. Chem.

Health Canada recently informed stakeholders, in particular manufacturers and importers of medical devices, of its intent to propose regulatory changes to strengthen post-market surveillance and risk management of medical devices in Canada. The proposed regulatory reforms will involve amendments to the Medical Devices Regulations.

Health Canada has cited several reasons for the proposed changes:

-  an increase in the complexity of medical devices;

-  an increase in the generation and use of real-world data and evidence amongst international regulators;

- a push for greater alignment of regulations with those of other countries; and

- a need for an environment that supports the integration of new technologies into the health care system while maintaining patient safety.

To review the proposed changes in full, please follow the link in the reference section below. 

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Reference:

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/noi-strengthening-post-market-surveillance-risk-management-medical-devices.htm