   
  
G/TBT/N/CAN/591/Add.1  
 
5 January 2021  
(21-0108) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English, French  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  4 January 2021 , is being circulated at the request of the 
delegation of Canada . 
 
_______________  
 
 
Title: Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations 
(Post-market Surveillance of Medical Devices)  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[X] Notified measure adopted - date: 4 December 2020  
[X] Notified measure published - date: 23 December 2020  
[X] Notified measure enters into force - date: 24 June 2021  
[X] Text of final measure available from1:  
http://www.gazette.gc.ca/rp -pr/p2/2020/2020 -12-23/html/sor -dors262-eng.html  
http://www.gazette.gc.ca/rp -pr/p2/2020/2020 -12-23/html/sor -dors262 -fra.html  
http://www.gazette.gc.ca/rp -pr/p2/2020/2020 -12-23/pdf/g2 -15426.pdf  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  The regulations modify the Medical Devices Regulations  (MDR) and the Food and Drug 
Regulations  (FDR) in order to operationalize provisions in the 2014 Protecting Canadians from Unsafe 
Drugs Act , as well as to add certain post -market surveillance provisions for medical devices. The 
provisions added to the MDR include:  
a. Allowing the Minister of Hea lth (the Minister) the power to compel an assessment of a marketed 
medical device;  
b. Allowing the Minister the power to compel additional tests and studies regarding a marketed 
medical device;  
c. Requiring product authorization holders to provide informat ion about foreign risk actions for their 
products;  
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final measure and/or interpretive guidance can be obtained.  G/TBT/N/CAN/591/Add.1  
 
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  d. Requiring certain medical device manufacturers to prepare summary reports; and  
e. Providing the Minister with the power to request that medical device manufacturers provide an 
analysis of the safety and  effectiveness of their products for the purpose of conducting a post -market 
safety assessment.  
Minor amendments to the FDR are made to support the changes to the MDR.  
The regulatory amendments, except those concerning the requirement to prepare summary r eports, 
will come into force on 24 June 2021. The amendments concerning the requirement to prepare 
summary reports will come into force on 24 December 2021.  
These regulations were previously notified in G/TBT/N/CAN/591 (dated 25 June 2019).  
__________  
 
 