G/TBT/N/CAN/692/Add.2  
 
8 January 2024  
(24-0167) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English, French  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  8 January 2024, is being circulated at the request of the 
delegation of Canada . 
 
_______________  
 
 
Title:  Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public 
Health Need): SOR/2023 -277 and  
Order Amending the Fees in Respect of Drugs and Medical Devices Order (Medical Devices for an 
Urgent Public Health Need): SOR/2023 -278 
 
Reason for Addendum:  
[ ] Comment period changed - date:   
[X] Notified measure adopted - date: 19 December 2023  
[X] Notified measure published - date: 3 January 2024  
[X] Notified measure enters into force - date: 3 January 2024  
[X] Text of final measure available from1:  
Regulations / Règlement:  
https://www.gazette.gc.ca/rp -pr/p2/2024/2024 -01-03/html/sor -dors277 -eng.html  
https://www.gazette.gc.ca/rp -pr/p2/2024/2024 -01-03/html/sor -dors277 -fra.html  
Order / Arrêté:  
https://gazette.gc.ca/rp -pr/p2/2024/2024 -01-03/html/sor -dors278 -eng.html  
https://gazette.gc.ca/rp -pr/p2/2024/2024 -01-03/html/sor -dors278 -fra.html  
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[ ] Content or scope of noti fied measure changed  and text available from1:  
New deadline for comments (if applicable):   
[ ] Interpretive guidance issued and text available from1:  
[ ] Other:  
 
Description:  The proposed changes notified in G/TBT/N/CAN/692/Add.1 (dated 21 August 2023) 
were adopted and published on January 3, 2024, as the Regulations Amending the Medical Devices 
Regulations (Medical Devices for an Urgent Public Health Need) (the Regulations).  
 
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.2  
 
- 2 - 
 
  The amendments to Medical Devices Regulations  (MDR) broaden the scope of Part 1.1, previously 
limited to COVID -19 medical devices, to apply to other future public health emergencies. The 
regulatory amendments also address a policy gap regarding application s in queue and clarify post -
market obligations. These amendments will facilitate timely access to safe and effective medical 
devices when future public health emergencies arise in Canada.  
In line with the previously published COVID -19 medical device framew ork, the broadened framework 
under Part 1.1 is optional. The general licensing framework under Part 1 of the MDR remains 
available for manufacturers to consider.  
The amendments to the MDR also resulted in administrative changes to the Fees in Respect of Dr ugs 
and Medical Devices Order (Fees Order). The Fees Order was amended to reflect the broadened 
scope of the amended Part 1.1 of the MDR and the fees that apply for Class II to IV medical devices 
authorized under Part 1.1 once they no longer meet an urgent  public health need.  
The Regulations and the Fees Order amendments came into force on January 3, 2024, the day on 
which they were published in the Canada Gazette , Part II.  
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