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

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

Published on August 20, 2018

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. 

Thank you for reading Regulated Affairs, the CAPRA Blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.

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

Related Articles

Pragmatic Clinical Trials: Testing Treatments in the Real-World

Pragmatic Clinical Trials: Testing Treatments in the Real-World

What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment...

The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – June 28, 2022

The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – June 28, 2022

The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862)....