Jan 5, 2021

As indicated in a previous blog post, Health Canada (HC) announced its intention to leave several Interim Orders relating to COVID-19 in place until at least the fall of 2021. By this time, the agency plans to have regulatory amendments in place that will maintain a balance between flexibility and regulatory oversight. In the weeks following this initial announcement, HC has released more information about the Interim Orders and its long-term plans.

HC will issue new Interim Order on importation and sale of medical devices for COVID-19

In a note issued to stakeholders, Health Canada stated that it will issue a second Interim Order maintaining the provisions of the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 until at least the fall of 2021. The current IO is scheduled to expire on March 18, 2021.

The second IO will give importers and distributors of authorized devices six months to obtain a Medical Device Establishment License (MDEL), and manufacturers will be required to provide bilingual labeling under certain circumstances. Once this IO expires, HC will implement transition regulations that would allow COVID-19 devices authorized under the IO to continue to be imported and sold for a specified period of time.

Authorizations for Class I devices are to remain valid for 18 months upon the transition regulations going into effect, while authorizations for Class II, III, and IV devices will remain valid for up to two years. Such authorizations are to be considered ​equivalent to a medical device license (MDL) under the Medical Devices Regulations (CMDR).

Under this plan, stakeholders will have to acquire MDLs and MDELs before the end of the transition period in order to continue importing and/or selling medical devices.

Regarding COVID-19 device applications for which HC has not issued a decision by the time the transition regulations come into effect, the agency will continue to review the applications against the IO criteria. If the application is successful, the validity of the authorization will only last until the end of the transition period for its given classification and will not be adjusted.​

HC provides details on regulatory amendments pertaining to COVID-19 clinical trials

HC issued an additional notice advising stakeholders on its plans to maintain the effects of the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 after the fall of 2021. This is to be accomplished through regulatory amendments that will allow sponsors to continue conducting clinical trials authorized under the IO and to utilize this pathway for new or later-phase COVID-19 clinical trials.

According to the notice, the proposed transition regulations will differ little from the contents of the IO. The only notable change will be to extend the requirement regarding retention of records beyond the duration of the IO and to align the records requirements with those outlined in the Medical Devices Regulations (CMDR).

New guidance issued to help stakeholders meet IO regulatory requirements

Finally, Health Canada published a guidance document relating to the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. The guidance is intended to help importers, distributors, manufacturers, and other establishments meet their regulatory requirements, such as:

  • Requesting medical devices to be added to the list of medical devices for exceptional importation and sale
  • Providing a notification of importation
  • Ensuring that information is accessible

Further information on the extension or replacement of COVID-19 IOs and the upcoming regulatory amendments will appear on this blog as it becomes available.

Related Health Canada medical device regulatory information from Emergo by UL:

Author

  • Timothy Herr

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