CANADA | Amendment of the Medical Devices Regulations to Create Permanent Framework for COVID-19 Medical Devices

The Canadian government has announced regulatory amendments to the Medical Devices Regulations (MDR) that will create a new permanent regulatory framework for COVID-19 medical devices. The amendments will allow for the continued importation and sale of over 800 COVID-19 medical devices authorized under Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

The new regulatory framework will maintain the regulatory flexibilities set out under the third interim order and permanently incorporate expedited authorization pathways and certain flexibilities for COVID-19 medical devices that meet an urgent public health need. However, once a COVID-19 medical device is no longer considered an urgent public health need, manufacturers will need to comply with additional requirements such as holding a Medical Device Establishment License and obtaining a Quality Management System certificate that is in compliance with the Medical Device Single Audit Program, and paying applicable fees.

The amendments will also make consequential changes to the MDR to provide greater alignment between the new regulatory framework and existing provisions. The MDR regulatory package will be accompanied by the Order Amending the Fees in Respect of Drugs and Medical Devices Order (COVID-19 Medical Devices) which will include fees for Class II to IV COVID-19 medical devices once the devices no longer meet the definition of an urgent public health need. Fees will apply for the examination of applications to amend an authorization being filed and annual right to sell fees. However, for COVID-19 medical devices that continue to meet an urgent public health need, fees will not apply.

This new regulatory framework will ensure that COVID-19 medical devices can continue to be imported and sold in Canada while maintaining safety and effectiveness requirements.

Notification: G/TBT/N/CAN/692