G/TBT/N/CAN/692/Add.1  
 
21 August 2023  
(23-5607) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English /French  
 
NOTIFICATION  
Addendum  
The following communication , dated  18 August 2023, is being circulated at the request of the 
delegation of Canada . 
 
_______________  
 
 
Title:  Proposed changes to Part 1.1 of the Medical Devices Regulations  to address future public 
health emergencies  
 
Reason for Addendum:  
[ ] Comment period changed - date:   
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[ ] Notified measure enters into force - date:  
[ ] Text of final measure available from1:  
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[X] Content or scope of notified measure changed  and text available from1:  
Proposed changes to the Medical Devices Regulations to address future public health 
emergencies:  
https://www.canada.ca/en/health -canada/programs/consultation -proposed -changes -
medical -devices -regulations -address -future -public -health -emergencies/notice.html  
(English ) 
https://www.canada.ca/fr/sante -canada/programmes/consultati on-modifications -
proposees -reglements -instruments -medicaux -repondre -futures -urgences -sante -
publique/avis.html  (French)  
New deadline for comments (if applicable):  8 September 2023  
[ ] Interpretive guidance issued and text available from1:  
[ ] Other:  
 
Description:  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. These regulations were notified in G/TBT/N/CAN/692 (dated 21 February 
2023) a nd resulted in the creation of Part 1.1 of the Medical Devices Regulations  (MDR).  
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/CAN/692/Add.1  
 
- 2 - 
 
  Canada is now proposing regulatory amendments to Part 1.1 of the MDR that would broaden the 
scope of Part 1.1, currently limited to COVID -19 medical devices, to apply to other future public 
health emergencies. The proposed amendments would also address a policy gap regarding 
applications in queue and clarify post -market obligations. These amendments would facilitate timely 
access to safe and effective medical devices when future public health emergencies arise in Canada. 
In line with the current COVID -19 medical device framework, the broadened framework under Part 
1.1 would be optional. The general licensing framework under Part 1 of the MDR would remain 
available for manuf acturers to consider.  
The proposed amendments to the MDR would also result in administrative changes to the Fees in 
Respect of Drugs and Medical Devices Order (Fees Order). The Fees Order would be amended to 
reflect the broadened scope of the amended Part 1.1 of the MDR and ensure fees apply for Class II 
to IV medical devices authorized under Part 1.1 once they no longer meet an urgent public health 
need.  
Canada consulted with stakeholders on this proposal and published a Notice of Intent (linked below) 
on March 23, 2023 to solicit feedback. The consultation was open for 21 days and closed on April 
13, 2023.  
The full text of the proposed measures can be downloaded from the Internet addresses indicated 
below:  
https://www.canada.ca/en/health -canada/programs/consultation -proposed -changes -medical -
devices -regulations -address -future -public -health-emergencies/notice.html  (English)  
https://www.canada.ca/fr/sante -canada/programmes/consultation -modifications -proposees -
reglements -instruments -medicaux -repondre -futures -urgences -sante -publique/avis.html  (French)  
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