Canada implements new regulations to strengthen post-market surveillance and risk management of medical devices

Heath Canada is making changes to its Medical Devices Regulations with the aim of improving their ability to identify, assess and manage new risks for medical devices used in Canada.

Following the 2019 creation of the Medical Devices Directorate which took a “lifecycle approach” to medical device regulation, Health Canada is looking to further strengthen this initiative by improving post-market surveillance effectiveness. The resultant post-market surveillance related amendments to the Medical Device regulations were first published in the Canada Gazette, Part II (CGII) on 23 December 2020.

Once the amending regulations have been published, four guidance documents will be released covering:

  • Incident reporting for medical devices
  • Foreign risk notification for medical devices
  • Summary reports and issue-related analyses of safety and effectiveness for medical devices
  • Guide to new authorities on the amendments to include power to require assessments and power to require tests and studies

These updates present the latest outcomes of Canada’s “Strengthening the use of real word evidence and regulations for medical devices” project, a component of their 5-year initiative on the regulatory review of drugs and devices.

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