Health Canada introduces PMS requirements for devices

Health Canada has written to all Medical Device Licence holders and Medical Device Establishment Licence (MDEL) holders in relation to the introduction of post-market surveillance requirements that amend the Medical Devices Regulations, as published in the Canada Gazette, Part II (Vol. 154, No. 26).

Health Canada explains that the changes have been made “to strengthen the lifecycle approach to the regulation of medical devices”.

The following provisions under the amended regulations will come into force on June 23, 2021:

• the power to require that a holder of a medical device licence conduct an assessment (section 62.1);
• the power to require that a holder of a medical device licence compile information, conduct tests or studies or monitor experience (section 62.2);
• the requirement of the holder of a medical device authorization to notify Health Canada of foreign actions taken in response to a serious risk of injury to human health (sections 61.2 to 61.3);
• the requirement to conduct issue-related analyses of safety and effectiveness (section 25(1) and section 39).

The following provision under the amended regulations will come into force on December 23, 2021:

• the requirement of the holder of a medical device licence to prepare summary reports and to notify Health Canada if there has been a change to what is known about the benefits and risks (sections 61.4 to 61.6).

A change has also been made to the requirements related to incident reporting (sections 59 to 61.1). Given the new requirement to notify Health Canada of foreign actions taken in response to a serious risk of injury to human health (sections 61.2 to 61.3), the reporting of foreign incidents will no longer be required for class II-IV medical devices as of June 23, 2021.

Guidance documents to support compliance with the new regulations will be published on the Health Canada web site in winter 2021. Shortly thereafter, Health Canada will also be hosting virtual information sessions to present the new regulations and the associated guidance documents. Details about the information sessions, including dates and how to participate, will be shared in January 2021.

For more information about the new regulations, please see the notice posted on the Health Canada web site.