Canada Health Canada, Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need): SOR/2023-277)

 

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) (the COVID-19 Medical Devices Regulations) came into force and created a permanent regulatory framework under Part 1.1 of the MDR for COVID-19 medical devices. Health Canada has expanded the scope of Part 1.1 from the provisions specific to COVID-19 to cover future urgent health emergencies.

Health Canada published the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) January 3, 2024 in Canada Gazette, Part II, Canada Gazette, Part II, Volume 158, Number 1.

 

The amendments to Medical Devices for an Urgent Public Health Need are briefly as follows.

1) List of Medical Devices for Expanded Use of Medical Devices with Urgent Public Health Need

-  Issue expanded use indications for Class II to IV authorizations under Part 1.1 or for devices licensed under Part 1 if there are reasonable grounds to believe there is an urgent public health need related to a listed corresponding medical condition.

2) Prohibition on advertising

- Prohibition has been added to restrict the advertising of Class I medical devices under Part 1.1

- Existing advertising prohibition for Class II, III and IV devices in the MDR

3) Applications in queue

- Remove the requirement for the device to be on the UPHN list when the Minister issues the authorization (This will allow Health Canada to continue to review an application that is in progress or in queue and the Minister to issue an authorization even if the UPHN list changes before a decision is made.)

4) Post-Market reporting

- The Regulations will clarify the post-market reporting obligations and make it more explicit that both the authorization holder and the importer of a Class II, III, or IV medical device that is removed from the UPHN list must report to the Minister information with respect to serious risk of injury to human health.

 

In addition, references to COVID-19 will be removed from the relevant sections of Part 1.1 of the MDR.

 

Please refer to the link below for more information.

https://gazette.gc.ca/rp-pr/p2/2024/2024-01-03/html/sor-dors277-eng.html

Canada Gazette, Part 2, Volume 158, Number 1: Regulations Amending the Medical Devices Regulations (Medical Devices for an Urge

---

If you have any questions about medical device,

Please contact us with the below.

info@jnmglobal.net

ra@jnmglobal.net