G/TBT/N/CAN/694  
19 April 2024  
(23-2811) 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:   
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  
Technical Barriers and Regulations Division  
Global Affairs Canada  
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 [X], 2.10.1 [  ], 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):  Drugs and 
medical devices (ICS codes: 11.120, 11.040)  
5. Title, number of pages and language(s) of the notified document:  Regulations 
Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, 
Establishment Licences and Finished Product Testing), (63 pages, available in English and 
French)  
6. Description of content:  The proposed amendments to the Food and Drug Regulations  
(FDR) would:  
· Establish a regulatory framework for recalls of drugs ordered by the Minister. Clarify 
reporting obligations for industry for voluntary (firm initiated) recalls.  
· Update the outdated references to foreign regulatory authorities who participate in 
mutual r ecognition agreements (MRA) with Canada and replace the outdated information 
with an ambulatory list of regulatory authorities incorporated by reference.  
· Offer conditional exemptions from requirements related to finished product testing for 
certain biolo gics (e.g., gene and cell therapies) and radiopharmaceuticals, as well as 
clarify that direct shipment to a person other than an importer (typically a healthcare 
provider) is permitted for these products.  G/TBT/N/CAN/694  
 
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  The proposed amendments for the Medical Devices Reg ulations  (MDR) would:  
· Update the definition of recall to include recalls ordered by the Minister, establishing a 
regulatory framework for recalls of medical devices ordered by the Minister, and clarifying 
the industry's reporting and record keeping oblig ations for firm -initiated recalls;  
· Improve international alignment relating to the reporting of low -risk medical device 
recalls;  
· Modernize the Medical Device Establishment Licence (MDEL) application requirements 
to reflect existing practices; and  
· Provide the Minister with the ability to issue terms and conditions on a MDEL to mitigate 
risks to health and safety, and strategically target non -compliance.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Health Canada is proposing regulatory amendments that target 
improvements to the regulation and oversight of therapeutic products in both the Food 
and Drug Regulations  and Medical Devices Regulations . The Department's Forward 
Regulatory Plan , Stock Review Plan , and the Health and Biosciences Sector Regulatory 
Review Roadmap  outline Health Canada's commitments to modernize the FDR and the 
MDR. These proposed regulations represent the first phase of work to modernize t he drug 
and medical device establishment licensing frameworks, as described in the Forward 
Regulatory Plan.  
Amending these regulations would strengthen our ability to provide efficient, effective 
and agile oversight of drugs and medical devices in a manner  that is better aligned with 
international best practices. The amendments include a number of changes to strengthen 
Health Canada's oversight of therapeutic products sold in Canada and to introduce 
additional risk -based measures and modern, flexible regula tory tools.  
These proposed regulatory changes would help to reduce administrative burden for 
industry wherever possible and improve international alignment.  
8. Relevant documents:   
Canada Gazette , Part I, April 15, 2023, pages 1263 -1325 (available in Engl ish and French)  
https://canadagazette.gc.ca/rp -pr/p1/2023/2023 -04-15/pdf/g1 -15715.pdf  
9. Proposed date of adoption:  On the day these regulations are registered.  
Proposed date of entry into force:  The proposed amendments to the FDR and MDR 
would come into force six months after the date of registration, except for two proposed 
amendments to the FDR. The proposed amendments respecting designated regulato ry 
authorities and finished product testing in the FDR would come into force immediately on 
the day the Regulations are registered.  
10. Final date for comments:  29 June 2023  
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 the following Web site:  
https://www.gazette.gc.ca/rp -pr/p1/2023/2023 -04-15/html/reg1 -eng.html  (English)  
https://www.gazette.gc.ca/rp -pr/p1/2023/2023 -04-15/html/reg1 -fra.html  (French)