Are you ready for the changes to Canada’s medical device regulations?

by | May 26, 2021 | MDR

Are you ready for the changes to Canada's medical device regulations

Medical device vigilance and post-market surveillance requirements are changing in Canada. Are you ready for the changes to Canada’s medical device regulations? If you are involved in the manufacture or import of medical devices for the Canadian market, you need to be aware of your updated obligations.

How do you make sure you comply?

  1. Review the updated Medical Devices Regulations and Guidance documents [available at:]
  2. Clarify which requirements apply to you
  3. Review your QMS to ensure that your procedures cover your updated requirements
  4. Maintain an awareness of the dates the new provisions come into force


Which products does this apply to?

When do the new or updated provisions come into effect?

Incident report for an incident occurring inside Canada

All Classes

23 June 2021

Incident report for an incident occurring outside Canada

Class I*

but see foreign risk notification requirement for Class II-IV devices

23 June 2021

Foreign risk notification

Classes II – IV

23 June 2021

Summary report

Classes II – IV

23 December 2021

Issue-related analysis

All Classes

23 June 2021

*Please note, existing requirements apply for reporting an incident outside of Canada for Class II – IV devices until the updated regulations come into force on 23 June 2021.

What are some of the notable changes?

Incident Reporting

Incident reports are no longer required for incidents occurring outside Canada for Class II, III or IV devices. [But see the section below regarding Foreign Risk Notification].

There is also a change in terminology in the guidance document from ‘mandatory problem reporting’ to ‘incident reporting’, and new definitions of ‘authorization holder’ and ‘serious risk of injury to human health’.

Foreign risk notification

Medical device licence holders and importers of Class II to IV devices must make a foreign risk notification to Health Canada within 72 hours. This applies where there is ‘a serious risk of injury to human health concerning a device authorized for sale in Canada’ and a notifiable action, such as recalls or suspensions or revocations of authorisations, is taken by the licence holder/importer or by regulatory authorities in certain jurisdictions.

Summary reports

Medical device licence holders for Class II to IV devices must prepare summary reports, assessing new information on the benefits and risks of the device. The time periods for the report depend on the device classification:

  • Class II – summary report every 2 years
  • Class III or IV – summary report every year

The summary report should include a critical analysis on the use of the devices, including information such as adverse effects, complaints or incidents, and needs to contain information specific to the Canadian context.

Where it is identified that there has been a change in the benefits and/or risks associated with a device, Health Canada must be notified within 72 hours. This could include submitting the report, submitting a medical device licence amendment application, or notifying Health Canada of a recall.

Where there is no change in the benefits and/or risks of the device, the report does not need to be submitted to Health Canada. Copies of summary reports and the supporting information and data should be kept for 7 years.

Issue-related analysis

Health Canada may at any time ask for an analysis of a safety or effectiveness issue for a device in any class.

New authorities:

There are also new regulatory powers, set out in the following sections of the Canadian Medical Devices Regulations:

  • Section 21.1 – Power to require and disclose information
  • Section 21.2 – Power to order a label change or package modification
  • Section 21.3 – Power to recall
  • Section 21.31 – Power to require assessment
  • Section 21.32 – Power to require tests, studies, etc.

IMed can help you identify your requirements

Our Global registration specialists can support you with market entry and compliance requirements across international territories. Please contact us for any advice you need on your global regulatory obligations.

Kate Christopher

Kate Christopher

IMed QA/RA Consultant

Click here to learn more about our Medical Device Services: