. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/COL/66 
3 June 2005  
 
(05-2277) 
Committee on Technical Barriers to Trade Original:   Spanish 
   
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member notifying:  COLOMBIA
 
If applicable, name of local government involved (Articles 3.2 and 7.2):    
2. Agency responsible:   Ministry of Social Welfare 
Name and address (including telephone and fax numbers and 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:   Ministry of 
Commerce, Industry and Tourism 
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 applic able, otherwise national tariff heading.  
ICS numbers may be provided in  addition, where applicable):   Medical devices and 
biomedical equipment 
5. Title, number of pages and langu age(s) of the notified document:   Draft Decree 
"Regulating the sanitary registration, marke ting approval and sanitary surveillance system 
for medical devices and biomedical equipment for human use" (34 pages, in Spanish). 
6. Description of content:   Purpose;  scope of application;  definitions;  accreditation;  basic 
safety and operating principles for medical devices and biomedical equipment;  classification of medical devices;  sound manufacturing practices;  production certificates;  storage;  conditioning;  sanitary registrati on system;  marketing approval;  general 
requirements for computer-controlled biomedical equipment;  importation of raw materials;  
general provisions governing la belling, packaging and labelling information;  control and 
surveillance;  information pertaining to mark et withdrawal;  traceability;  sampling;  and 
sanitary measures. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
 Protect human health and safety and prevent practices likely to mislead consumers. 
8. Relevant documents:   Law 09 of 1979, Article 245 of Law 100 of 1993, and Article 42.3 
of Law 715 of 2001. 
9. Proposed date of adoption:  9 September 2005  
Proposed date of entry into force:  Six (6) months as from the date of publication in the 
              Official Journal. 
10. Final date for comments:   1 September 2005 G/TBT/N/COL/66 
Page 2  
 
11. Texts available from:  National enquiry point [ X ], 
Enquiry Point 
Contact person: Daniel Héctor Rico R.  E-mail: danielrico@mincomercio.gov.co 
Tel.: (+571) 606-7676, Ext. 1690 
Fax: (+571) 241-0480  Ministerio de Comercio, Industria y Turismo Dirección de Regulación 
Calle 28 No. 13A - 15, cuarto piso 
Bogotá, D.C., Colombia  Tel.: (+571) 241-0478 Web site: 
http://www.mincomercio.gov.co/VBeCont ent/NewsDetail.asp? ID=2197&IDCompany=15
 
or address, telephone and fax numbers and E-mail and Web site addresses, if 
available, of other body:    
Ministerio de la Protección Social 
Dirección General de Calidad de Servicios 
Carrera 13 No. 32 - 76 
Bogotá, D.C., Colombia  E-mail: bolarte@minproteccionsocial.gov.co
 
Tel.: (571) 336-5066 Fax:  (571) 336-0182 
Web site: www.minsalud.gov.co