. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/153 
16 December 2005 
 (05-6107) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   CANADA  
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Department of Health 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:    
Canadian Enquiry Point 
200-270 Albert Street Ottawa, Ontario Canada K1P 6N7 
 
Tel.:  (+1 613) 238 3222 Fax.:  (+1 613) 569 7808 E-mail:  info@scc.ca
 
3. Notified under Article 2.9.2 [  X ], 2.10.1 [   ], 5.6.2 [ X ], 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):   Human Cells, Tissues 
and Organs for Transplantation (ICS:  11.040) 
5. Title, number of pages and language(s) of the notified document:   Proposed Safety of 
Human Cells, Tissues and Organs for Transpla ntation Regulations (pages 4067-4115; in 
English and French) 
 
Proposed Amendment to the Medical Devices Regulations (pages 4116-4117;  in English 
and French)  Proposed Amendment to Schedule D to the Food and Drugs Act (Blood and Blood Derivatives) (pages 4118-4119;  in English and French)  
6. Description of content:   The purpose of this regulatory initiative is to minimize the 
potential health risks to Canadian recipients  of human cells, tissues and organs (CTO). 
These proposed Safety of Human Cells, Tissues and Organs for Transplantation 
Regulations (CTO Regulations) will address safety in the processing and handling of these 
products, resulting in improved protection of the health and safety of Canadian transplant 
recipients.  G/TBT/N/CAN/153 
Page 2  
 
As the CTO Regulations are implemented, a c onsequential amendment to Schedule D to the 
FDA will also be required.  The proposed CTO Regulations will cover cord blood and 
peripheral blood when used as a source of ly mphohematopoietic cells intended for use in 
transplantation, while cord blood and peri pheral blood intended for transfusion will 
continue to be regulated in Schedule D to the FDA.  
 
The Medical Devices Regulations (MDR) will also be amended upon implementation of the 
CTO Regulations.  The intention is to limit the scope of the MDR to medical devices manufactured from or incorporating animal or human cells or tissues.  To allow for an appropriate transition, it is proposed that h eart valves and dura mater will remain under the 
MDR until Phase II, when they will be regulated under the CTO Regulations.  
 
Regulatory framework for CTO  
 
The regulatory framework for CTO will be introdu ced in two phases.  The main objective of 
the Phase I regulations is to maximize the safety of CTO, by clearly stipulating the safety 
requirements adopted from the National Standa rds (CAN/CSA Z900 package), thus making 
them mandatory.  The Regulations will set out  basic safety requirements with respect to 
donor screening, donor testing, collection/retr ieval, processing, preservation, packaging, 
labelling, storage, quarantine, record keeping,  distribution, importation, error, accident and 
adverse reaction monitoring and repor ting, investigation and recall.  
 
Phase II of the regulatory framework for CTO will include more comprehensive compliance monitoring and enforcement provisions, and surveillance and adverse reactions reporting 
strategies.  In Phase II, heart valves and dura mater (lining of the brain) will fall under the CTO Regulations.  At that time, an amendment to the Phase I Regulations will be required 
to incorporate heart valves and dura mater into the CTO Regulations, as well as a 
simultaneous amendment to remove them from the MDR.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health and safety 
8. Relevant documents:   Canada Gazette, Part I, 10 December 2005 
9. Proposed date of adoption:  Normally within 6 to 8 months of publication in the Canada 
Gazette, Part I 
Proposed date of entry into force:  On the date the measure is adopted. 
10. Final date for comments:   23 February 2006 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses,  if available of the other body:  The electronic 
version of the regulatory text can be downloaded at:   http://canadagazette.gc.ca/partI/2005/20051210/pdf/g1-13950.pdf