  
  
G/TBT/N/CAN/692  
21 February 2023  
(23-1227) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English /French  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  CANADA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Health Canada  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Canada's Notification Authority a nd Enquiry Point  
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive  
Ottawa (Ontario) K1A 0G2  
Canada  
Telephone: (343)203 -4273 
Fax: (613)943 -0346 
Email: enquirypoint@international.gc.ca  
3. Notified under Article 2.9.2 [  ], 2.10.1 [X], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medical 
Devices  
5. Title, number of pages and language(s) of the notified document:  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), (56 pages, 
available in English and French) and the Order Amending the Fees in Respect of Drugs 
and Medical Devices Order (COVID -19 Medical Devices), (12 pages, availa ble in English 
and French).  
6. Description of content:  Regulatory amendments to the Medical Devices Regulations 
(MDR) will create a new permanent regulatory framework for COVID -19 medical devices.  
The amendments will allow for the continued importation a nd 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 third interim order).  
As well, the amendments will maintain the regulatory flexibi lities set out under the third 
interim order. The amendments will also permanently incorporate from the third interim 
order the expedited authorization pathways and certain flexibilities for COVID -19 medical 
devices that meet an urgent public health need.  
Once a COVID -19 medical device is no longer considered an urgent public health need, 
manufacturers will need to comply with additional requirements (e.g., hold a Medical G/TBT/N/CAN/692  
 
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  Device Establishment License, obtain a Quality Management System certificate that is i n 
compliance with the Medical Device Single Audit Program, pay applicable fees) if they 
wish to continue to import or sell their medical device in Canada. These are requirements 
that are normally met by manufacturers for other medical devices authorized in  Canada.  
Consequential amendments will also be made 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) (Fees Order) .  
The Fees Order will be amended to 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  
For COVID -19 medical devices that continue to meet an urgent public health need, fees 
will not apply.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objectives of the Regulations are to:  
• enable manufacturers, importers and distributors to continue to import or sell 
COVID -19 medical devices authorized under the third interim order and provide 
a permanent regulatory framework for these devices;  
• maintain the regulatory flexibilities set out under the third interim order for 
COVID -19 authorizations while there is  an urgent public health need for the 
devices;  
• enable new authorizations for COVID -19 medical devices and expanded use 
indications to be issued when there is an urgent public health need;  
• continue many of the regulatory obligations, and other requirements originally 
set out in the third interim order after the interim order expires, as well as existing 
applications in queue; and  
• introduce additional requirements for long -term oversight of the authorized 
devices that are in line with requirements other medical devices are subject to in 
the MDR, once a COVID -19 medical device is no longer considered required to 
meet an urgent public health need.  
The objective of the Fees Order amendments is to introduce fees for Class II to IV COVID -
19 medical devices onc e they no longer meet the definition of an urgent public health 
need.  
8. Relevant documents:   
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  
• Canada Gazette , Part II, 15 February 2023, pages 549 – 604 
Order Amending the Fees in Respect of Drugs and Medical Devices Order (COVID -19 
Medical Devices)  
• Canada Gazette , Part II, 15 February 2023, pages 624 – 635 
https://www.gazette.gc.ca/rp -pr/p2/2023/2023 -02-15/pdf/g2 -15704.pdf  (available in 
English and French)  G/TBT/N/CAN/692  
 
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  9. Proposed date of adoption:  On date of registration (3 February 2023)  
Proposed date of entry into force:  The MDR amendments and Fees Order amendments 
will come into force the day after Interim Order No. 3 Respecting the Importation and 
Sale of Medical Devices for Use in Relation to COVID -19 ceases to have effe ct (i.e., 22 
February 2023). This will allow for the continued importation and sale of authorized 
COVID -19 medical devices.  
10. Final date for comments:  Not Applicable; These regulatory amendments have been 
granted an exemption from publication in Canada Gazette, Part I, and therefore a pre -
consultation was not conducted.  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
The electronic version of the regulatory text can be found at:  
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 
https://canadagazette.gc.ca/rp -pr/p2/2023/2023 -02-15/html/sor -dors19 -eng.html  
(English)  
https://canadagazette.gc.ca/rp -pr/p2/2023/2023 -02-15/html/sor -dors19 -fra.html  
(French)  
Order Amending the Fees in Respect of Drugs and Medical Devices Order (COVID -19 
Medical Devices)  
https://canadagazette.gc.ca/rp -pr/p2/2023/2023 -02-15/html/sor -dors21 -eng.html  
(English)  
https://canadagazette.gc.ca/ rp-pr/p2/2023/2023 -02-15/html/sor -dors21 -fra.html  
(French)  
 