G/TBT/N/CAN/550  
 
24 April 2018  
(18-2547) 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 Notification 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. I CS numbers may be provided in addition, where applicable): Disinfectant 
Drugs; Class II Medical Devices (ICS: 11.040)  
5. Title, number of pages and language(s) of the notified document: Notice on the 
Classification and Licensing of High -Level Disinfectants and Sterilants as Medical Devices 
(1 page, available in English and French)   
6. Description of content: As one initiative under the Canada -United States Regulatory 
Cooperation Council (RCC), Health Canada is reclassifying high -level disinfec tants and 
sterilant solutions, including contact lens disinfectants, intended for use on medical 
devices. These products are being reclassified from drugs to medical devices to better align 
Canadian regulatory requirements with those of the United States. All medical device 
disinfectants and sterilants that do not meet the definition of an antimicrobial agent, as 
defined in section C.01A.001(1) of the Food and Drug Regulations  (FDR) are no longer 
regulated under the FDR and are subject to the requirements o f the Medical Devices 
Regulations . Health Canada is allowing an 18 -month transition period from the date of this 
publication for manufacturers of market authorized disinfectants and sterilants to obtain 
quality management system (QMS) certificates. Further  information on how to obtain a 
QMS certificate is available at www.canada.ca/en/health -canada/services/drugs -health -
products/me dical-devices/quality -systems -13485.html  . 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Improve regulatory alignment between Canada and United States  G/TBT/N/CAN/550  
 
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  8. Relevant documents:  Web-posted document   
9. Proposed date of adoption: 16 March 2018 (date of publication of Notice on Health 
Canada's website)  
Proposed date of entry into force: 16 September 2019  
10. Final date for comments: 17 June 2018  
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.canada.ca/en/health -canada/services/drugs -health -products/medical -
devices/activities/announcements/notice -classification -licensing -high-level-disinfectants -
sterilants.html  
https://www.canada.ca/fr/sante -canada/services/medicaments -produits -
sante/instruments -medicaux/activites/annonces/avis -classification -homologation -
desinfectants -haut-niveau -agents -sterilisants.htm