Guidance on clinical evidence requirements for medical devices: Additional obligations during post-market phase

Date published: November 15, 2022

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• Requirements as set out in terms and conditions
• During the post-market phase

After Health Canada issues a medical device licence, we may require a manufacturer to submit additional clinical evidence to support the device's continued safety and effectiveness. Follow the guidelines in this guidance document, paying special attention to the section on generating clinical data from post-market clinical experience.

Requirements as set out in terms and conditions

Terms and conditions may be imposed on some medical device licences that are issued by the Minister. Additional information may also be requested to ensure the device continues to meet safety and effectiveness requirements after it's been approved.

As per subsection 36(2) of the Medical Devices Regulations (Regulations), the Minister may set out in a medical device licence terms and conditions respecting:

• the tests to be performed on a device to ensure that it continues to meet the applicable requirements of sections 10 to 20 and
• the requirement to submit the results and protocols of any tests performed

As per subsection 36(3), the Minister may amend the terms and conditions of the medical licence to take into account any new development with respect to the device. The holder of the medical device licence shall comply with the terms and conditions of the licence as per subsection 36(4).

Factors that may trigger Health Canada to impose terms and conditions vary with each type of device and/or situation. They include the following:

• longer-term clinical follow-up is ongoing for medical devices with an expected useful life that is longer than the clinical data provided or was not available at the time of licence application (typically beyond 1 to 2 years)
• uncertainty related to clinical performance of the subject device or technology in less experienced clinical settings or centres (for example, fewer health care professionals experienced in using the device or technology) than those who were involved in the clinical investigations
• uncertainty related to clinical performance in patient populations that may not have been adequately represented in clinical investigations
• determination of the frequency of possible rare adverse events that may not have been observable in the clinical investigation, due to its limited timeframe

Manufacturers will be required to submit the newly collected or assembled clinical data or evidence if the terms and conditions:

• consist of follow-up of existing clinical investigations or specifically designed post-market studies or
• are intended to collect long-term safety and/or effectiveness data

Health Canada will assess the evidence received in response to the requirements of the terms and conditions as part of the overall monitoring of the safety and effectiveness of a marketed medical device.

During the post-market phase

Health Canada may ask a manufacturer to submit information in its possession through Section 39 of the Regulations when there's a reasonable belief that a licensed medical device may not continue to meet safety and effectiveness requirements after it's marketed.

Safety issues that have occurred in Canada or incidents that have been identified in other jurisdictions may trigger this request.

Manufacturers must submit the required evidence and are encouraged to use the format specified in the request. These requests may include requests for clinical evidence. The guidelines in this guidance document for the submission of clinical data and clinical evidence continue to apply.