ARCHIVED Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices: Notice

Date published: 2023-02-22

On this page

• Background
• About the amendments
• What this means for authorization holders
• What this means for authorized devices not on UPHN list
• What this means for purchasers and users
• Summary reporting
• Contact us

Background

Health Canada made 3 interim orders to authorize the importation and sale of medical devices used to diagnose, treat, mitigate or prevent COVID-19. The interim orders were put in place to accelerate access to these medical devices in Canada during the pandemic. Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3) took effect on February 21, 2022, and expired on February 21, 2023.

On February 22, 2023, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) (Regulations) came into force. These Regulations are located in Part 1.1 of the Medical Devices Regulations (MDR).

We introduced these Regulations to continue accelerated access to COVID-19 medical devices for which there is an urgent public health need without relying on temporary regulatory measures.

About the amendments

These Regulations:

• create a permanent regulatory framework for COVID-19 medical devices
• continue to maintain most of the flexibilities introduced by IO No. 3 for devices that are on the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 (UPHN list)

Part 1.1 of the MDR will provide the same pathway as under IO No. 3 to issue an authorization for:

• new COVID-19 medical devices that are on the UPHN list
• expanded use indications added by the Minister related to COVID-19 for existing devices licensed or authorized under the MDR
• COVID-19 medical devices that are on the UPHN list and leverage an authorization by a regulatory agency that is on the List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulation

To support the Regulations, we have published the following guidance document:

• Medical devices for use in relation to COVID-19

This guidance document explains how to apply for an authorization to import and sell COVID-19 medical devices.

What this means for authorization holders

Part 1.1 of the MDR allows manufacturers, importers and distributors to continue to import and sell COVID-19 medical devices that were authorized under IO No. 3. For example:

• All active authorizations under IO No. 3 are considered authorizations for importation and sale under these Regulations.
  • No immediate action is required from the manufacturer if the device is on the UPHN list.
• Applications submitted by manufacturers under IO No. 3 for which we have yet to issue a decision are considered active applications under these Regulations.
  • These include applications for amendments of authorized devices and new applications for authorization.
  • No immediate action is required from the manufacturer.

Upon the coming into force of the Regulations, the following continue to apply:

• expanded use indications on the List of Medical Devices for Expanded Use in Relation to COVID-19
• any outstanding terms and conditions imposed on interim order authorizations are considered imposed under these Regulations
• all requests for additional information or materials made by the Minister are considered as requests under these Regulations

What this means for authorized devices not on UPHN list

Authorization holders of a COVID-19 medical device not on the UPHN list will need to comply with additional requirements to continue to import and sell the device. The requirements will depend on the class of the device. When a COVID-19 medical device is no longer on the UPHN list, we will inform the authorization holder of additional requirements that apply.

Once a COVID-19 medical device is no longer on the UPHN list, the following additional requirement will apply:

• Manufacturers of a Class I COVID-19 medical device may continue to import and sell their medical device if they:
  • apply for a medical device establishment licence (MDEL) within 120 days after the day on which the device ceases to be on the UPHN list
  • obtain an MDEL
  • pay associated MDEL fees
• Manufacturers of a Class II, III or IV COVID-19 medical device may maintain their authorization if they:
  • submit a certification contract to the Minister, within 120 days after the day on which the device ceases to be on the UPHN list, to indicate that the certification process under the Medical Device Single Audit Program (MDSAP) has been initiated
  • submit a MDSAP-compliant quality management system certificate within 2 years after the day on which the device ceases to be on the UPHN list
  • pay all applicable fees
  • comply with annual review requirements
  • report information concerning a serious risk of injury to human health in specified foreign jurisdictions
  • prepare summary safety reports

We also amended the Fees in Respect of Drugs and Medical Devices Order. For more information on the applicable fees, please consult the following guidance document:

• Fees for the review of medical device licence and COVID-19 authorization amendment applications

What this means for purchasers and users

Purchasers and users are not affected, as devices authorized under Interim Order No. 3 may continue be sold under the Regulations.

Anyone, other than the device manufacturer, who imports or distributes an interim order-authorized device for use in Canada must obtain a medical device establishment licence (MDEL). Health care facilities and retailers are exempt from holding an MDEL.

For details on who needs to hold an MDEL and how to submit an application, please consult the following guidance document:

• Guidance on medical device establishment licences (GUI-0016)

Find more details on authorized medical devices for uses related to COVID-19.

Summary reporting

Health Canada amended sections 61.4 to 61.6 of the MDR (summary reporting provisions) to:

• align with the summary reporting provisions used in Part 1.1 of the MDR
• clarify the language found in the summary reporting provisions

While the language in the Regulations has been revised to be clearer, the intent is the same.

To understand and comply with the regulatory requirements for summary reports, refer to the following guidance document:

• Guidance on summary reports and issue-related analyses for medical devices

Contact us

For more information, please contact our Medical Devices Directorate at mddpolicy-politiquesdim.sc@hc-sc.gc.ca.

For questions about the MDEL process, please email us at mdel.questions.leim@hc-sc.gc.ca.

For questions about your particular authorization or application or about new applications, please email us at devicelicensing-homologationinstruments@hc-sc.gc.ca.