G/TBT/N/CAN/591  
 
25 June 2019  
(19-4285) Page: 1/2 
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:  Department of Health  
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 No tification Authority and Enquiry Point  
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive, Ottawa, ON K1A 0G2  
Canada  
Telephone: (343)203 -4273 
Fax: (613)943 -0346 
E-mail: enquirypoint@international.gc.ca  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other  [  ]:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Drugs and 
Medical devices (ICS: 11.040, 11.120)  
5. Title, number of pages and language(s) of the notified document:  Regulations 
Amending Certain Regulations Made Under the Food and Drugs Act (Post -market 
Surveillance of Medica l Devices) (43 pages, available in English and French)  
6. Description of content:  The proposed regulations will modify the Medical Device 
Regulations  (MDR) and the Food and Drug Regulations  (FDR) in order to operationalize 
provisions in the 2014 Protectin g Canadians from Unsafe Drugs Act , as well as to add 
certain post -market surveillance provisions for medical devices. The provisions that are 
being proposed to be added to the MDR include:  
a) allowing the Minister of Health (the Minister) the power to com pel 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 information about foreign risk actions 
for their products;  
d) requiring medical device ma nufacturers to prepare annual 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 safet y assessment.  G/TBT/N/CAN/591  
 
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  Minor amendments will be made to the FDR to support the changes to the Medical Device 
Regulations.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The proposed regulatory amendments are intended to enabl e Health Canada 
to regulate medical devices more efficiently and effectively, based on a life cycle 
approach. The regulatory amendments are necessary to specify how and when the 
Minister may exercise key provisions from Vanessa's Law such as the power to o rder an 
assessment or tests and studies. These are important tools for Health Canada to be able 
to effectively monitor medical devices once on the market and to act in a timely manner 
upon important post -market safety information.  
8. Relevant documents:   
• Food and Drugs Act  
https://laws -lois.justice.gc.ca/eng/acts/F -27/  (English)  
https://laws -lois.justice.gc.ca/fra/lois/F -27/ (French)  
• Medical Devices Regulations  
https://laws -lois.justice.gc.ca/eng/regulations/sor -98-282/  (English)  
https://laws -lois.justice.gc.ca/fra/reglements/DORS -98-282/ (French)  
• Food and Drugs Regulations  
https://laws.justice.gc.ca/eng/regulations/c.r.c.,_c._870/index.html  (English)  
https://laws.justice.gc.ca/fra/reglements/C.R.C.%2C_ch._870/index.html  
(French)  
9. Proposed date of adoption:  On the date the amendments are registered, notification 
of registration will occur through publication in Canada Gazette, Part II, which is 
anticipated to be 6 months following publication in Canada Gazette, Part I.  
Proposed date of entry into force:  It is proposed these regulations would come into 
force 6 months after the day on which they are published in the Canada Gazette, Part II.  
10. Final date for comments:  70 days from date of posting in Canada Gazette, Part I  
11. Texts available from:  National enquiry point [X] 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 downloaded at:  
http://www.gazette.gc.ca/rp -pr/p1/2019/2019 -06-15/html/reg7 -eng.html   
http://www.gazette.gc.ca/rp -pr/p1/2019/2019 -06-15/html/reg7 -fra.html