A permanent regulatory framework for COVID-19 medical devices

Since March 2020, the Government of Canada had issued three consecutive medical device interim orders to provide accelerated importation and sale of COVID-19 medical devices in Canada. The third interim order 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) came into force. The amendments create a new Part 1.1 to the Medical Devices Regulations (MDR), aimed at providing a permanent regulatory framework for COVID-19 medical devices, while maintaining flexibilities provided under the third interim order.

What you need to know

• Permanent regulatory pathway for COVID-19 medical devices. Part 1.1 of the MDR largely aligns with the provisions from the third interim order and provides an alternative expedited authorization pathway for COVID-19 devices under the MDR.
• Continued access to COVID-19 medical devices. The amendments enable manufacturers, importers and distributors to continue importing and selling COVID-19 devices authorized under the third interim order. All authorizations issued and expanded use indications permitted under the third interim order are carried over to Part 1.1 of the MDR.
• Accelerated approval pathways. Part 1.1 of the MDR retains the same expedited authorization pathways provided in the third interim order:
  • new COVID-19 medical devices on the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 (the UPHN list);
  • expanded use indications for previously authorized devices¹; and
  • COVID-19 medical devices on the UPHN list that have been approved by a foreign regulatory authority².
    
    Applications in queue under the third interim order are carried over and reviewed against criteria of Part 1.1 of the MDR.
• Labelling. Authorization holders under Part 1.1 of the MDR need to meet labelling requirements in the MDR. Manufacturers that received an authorization under the third interim order have until August 22, 2023 to comply with the labelling requirements under the MDR.

Additional information

Continued regulatory flexibilities

While COVID-19 medical devices are on the UPHN list, authorization holders benefit from the same flexibilities provided under the third interim order, including exemption from establishment license and quality management system certificate requirements. The amendments allow the Minister of Health to continue using discretion in determining the level of evidence required to demonstrate the safety and efficacy of the devices authorized to meet an urgent public health need.

Post-market requirements

Authorization holders must comply with post-market requirements related to distribution records, complaint handling and recalls, incident reporting and reporting of shortages. Similar to other medical devices, authorization holders of COVID-19 medical devices must inform the Minister within 30 days of discontinuance if they choose to discontinue the sale of their device in Canada.

COVID-19 medical device removed from the UPHN list

For Class I COVID-19 medical devices, if the device is no longer on the UPHN list, the authorization holder must comply with the general requirements under the MDR relating to the import and sale of medical devices. The authorization holder has 120 days after the device is removed from the UPHN list to apply for an MDEL.

For Class II to IV COVID-19 medical devices, the authorization holder can maintain the COVID-19 authorization under Part 1.1 of the MDR after the device is removed from the UPHN list by complying with the additional requirements specified in Part 1.1, including obtaining and maintaining a quality management system certificate, completing an annual review and complying with reporting obligations.

Importers and distributors

Under Part 1.1 of the MDR, importers and distributors must continue to hold a MDEL in order to import/distribute COVID-19 medical devices and must comply with post-market requirements related to distribution records, incident reporting, complaint handling and recalls. If an authorization under Part 1.1 of the MDR is cancelled, importers and distributors are granted six months to sell off existing inventory if the labelling and MDEL requirements are met.

What’s next

The amendments creating Part 1.1 of the MDR are now law. Health Canada has published accompanying guidance documents in relation to Part 1.1 of the MDR to assist manufacturers with interpretation of these new rules.

The amended MDR imposes certain regulatory requirements that go beyond those provided in the third interim order. As such, we recommend that manufacturers, importers and distributors of COVID-19 medical devices familiarize themselves with the amended MDR to ensure compliance with the new regulatory requirements provided in the amended MDR.