. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/COL/79 
26 June 2006 
 (06-3102) 
Committee on Technical Barriers to Trade  Original:   Spanish 
 
 
NOTIFICATION 
 
The following notification is being circulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:  COLOMBIA  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:   Ministerio de la Protección Social  (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:  
Ministerio de Comercio, Industria y Turismo  (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):  Prescription ophthalmic 
medical devices  
5. Title, number of pages and lang uage(s) of the notified document:   Proyecto de Decreto 
"Por el cual se expide el Reglamento Técnic o sobre los requisitos que deben cumplir los 
dispositivos médicos sobre medida para la salud visual y ocular y los establecimientos en 
los que se elaboren y comercialicen dichos  insumos y se dictan otras disposiciones"  (Draft 
Decree "Issuing the Technical Regulat ion on the require ments for prescription medical 
devices for visual and ocular health and the establishments which manufacture and market 
such devices, and adopting other prov isions") (18 pages, in Spanish). 
6. Description of content:   This draft Decree covers the following:  Purpose and scope o f 
application, Definitions, Essential requirements governing the safety and performance of 
prescription medical devices for visual and ocular health;  Technical, health and hygiene conditions of establishments which manufactur e and market prescription medical devices 
for visual and ocular health;  Human resources;  Certificates of qualification to produce, fit and dispense prescription medical devices for visu al and ocular health;  Pre scription of corrective medical devices for visual and ocular health;  Disp ensation of prescription medical devices for visual and ocula r health;  Packaging, la belling and advertising; Monitoring and control, and Period of validity and final provision. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
 Protection of human health and safety and prevention of practices likely to mislead 
consumers. G/TBT/N/COL/79 
Page 2  
 
  8. Relevant documents:   Law No. 09 of 1979, Article 245 of Law No. 100 of 1993 and  
Article 42.3 of Law No. 715 of 2001. 
9. Proposed date of adoption:  Upon publication in the Official Journal.  
Proposed date of entry into force:  Six (6) months after the date of publi cation in the 
Official Journal. 
10. Final date for comments:   22 September 2006 
11. Texts available from:  National enquiry point [ X ], or address, telephone and fax 
numbers and E-mail and Web site addresses, if available, of other body:  
Enquiry Point : 
Contact person:  Daniel Héctor Rico R. 
Tel.: (+571) 606-7676, Ext. 1690 
Fax: (+571) 241-0480 E-mail: danielrico@mincomercio.gov.co 
Ministerio de Comercio, Industria y Turismo 
Dirección de Regulación 
Calle 28 Nº 13A - 15, tercer piso 
Bogotá, D.C., Colombia Tel.: (+571) 241-0478 Web site:  http://www.mincomercio.gov.co
 
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 Tel.: (+571) 336-5066 
Fax: (+571) 336-0182 
E-mail: mcrodriguez@minproteccionsocial.gov.co Web site: www.minsalud.gov.co