G/TBT/N/CAN/430
27 October 2014 
(14-6210)  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 telephon e 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 and Enquiry Point 
Foreign Affairs, Trade and Development Canada 
Technical Barriers and Regulations Division (TIB) 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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Class II medical devices 
(ICS 11:040) 
5. Title, number of pages and language(s) of the notified document: Proposed 
Amendments to the Medical Devices Regulations (Non-Corrective Contact Lenses and 
Labelling of Class II Medical Devices) (7 pages, available in English and French)     
6. Description of content: This proposal would introduce two sets of amendments to the 
Medical Devices Regulations , both involving the licence application requirements for Class 
II medical devices.  
The first amendment would address the absence of therapeutic effect in non-corrective 
contact lenses.  Non-corrective contact lenses are currently subject to the Canada 
Consumer Product Safety Act  and therefore do not require a licence from Health Canada 
prior to being imported or sold in Canada.  Bill C-313, An Act to Amend the Food and 
Drugs Act (non-corrective contact lens)  received Royal Assent on December 14, 2012.  
Once this Act comes into force, these products would become subject to all of the licensing requirements for Class II devices under the Medical Device Regulations.   However, an 
exemption would be made so that manufacturers of non-corrective contact lenses would 
not be required to demonstrate therapeutic effectiveness for these products. The proposed 
amendments to the Medical Devices Regulations  and to the Food and Drugs Act  would 
come into force at the same time.   
Since 2005, all contact lenses (both corrective and non-corrective) have been regulated as 
medical devices in the United States.  The proposal would align the Canadian regulatory approach more closely with our largest trading partner.   G/TBT/N/CAN/430 
 
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  The objective of the proposed regulation for non-corrective lenses is to enable proportional 
regulatory oversight with regard to the ma nufacture and safe use of these products, 
without imposing an undue burden on the manufacturer. 
The second amendment to the Medical Devices Regulations  would require manufacturers of 
all Class II devices to submit a copy of the product label as part of the Class II medical device licence application.  Currently, manufacturers of Class II devices are not required to 
provide a copy of the product label with a licence application.  Instead, a Class II licence 
application requires only an attestation that the label complies with the requirements of the Regulations .   
The regulation with respect to labelling of Class II medical devices is intended to address 
concerns of non-compliant labelling and inappropriate risk classification of medical devices so that the level of regulatory oversight applied to a device is proportional to the risk presented by its use. 
 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health and safety (safe use of medical devices) 
8. Relevant documents:  Canada Gazette, Part I, 18 October 2014, pages 2718-2725 
(available in English and 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 6-9 months following publication in Canada Gazette, Part I. 
Proposed date of entry into force:   The concurrent coming into force of the proposed 
amendments to the Medical Devices Regulations and the Food and Drugs Act for Non-Corrective Contact Lenses would come into force 12 months following publication in Canada 
Gazette, Part II.   
The amended Regulations to address Class II device labelling would come into force on the 
day on which they are registered.   
10. Final date for comments: December 31, 2014  
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 downloaded at: http://www.gazette.gc.c a/rp-pr/p1/2014/2014-10 -18/pdf/g1-14842.pdf  (Canada Gazette)  
http://gazette.gc.ca/rp-pr/p1/20 14/2014-10-18/html/reg4-eng.php   
http://gazette.gc.ca/rp-pr/p1/20 14/2014-10-18/html/reg4-fra.php