. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/COL/108 
25 February 2008 
 (08-0815) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated 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  – Dirección General de Calidad 
de Servicios (Ministry of Social Welfare – Directorate-General of Service Quality) 
Name and address (including telephone and fax numbers and E-mail and website 
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 Trade, Industry and Tourism) 
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.
ICS numbers may be provided in addition, where applicable):   Prescription medical 
devices for visual and ocular health, such as ophthalmic lenses, frames, contact lenses, 
orbital implants, ocular prostheses and other prosthetic accessories, glasses, and optical and non-optical aids. 
5. Title, number of pages and lang uage(s) of the notified document:   Proyecto de 
Resolución del Ministerio de la Protección Social "Por la cual se establecen las condiciones técnico sanitarias de los establ ecimientos en los que  se elaboren, procesen, 
adecuen, almacenen, comercialicen, distribuy an o dispensen dispositivos médicos sobre 
medida para la salud visual y ocular" (Draft Resolution of the Ministry of Social Welfare 
"establishing the technical and sanitary requirements for establishments which manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual 
and ocular health") (18 pages, in Spanish).  
6. Description of content:   The notified draft Resolution establishes the technical and sanitary 
requirements for establishments which manuf acture, adjust, process, store, market, 
distribute or dispense prescription medical devi ces for visual and ocular health.  Reference 
is made to the following:  human resources;   organization;  sanitation and hygiene;  
installations;  opticians;  optical workshops or ophthalmic laboratories of low complexity 
and ocular prosthesis laboratories;  ophthalmic laboratories;  contact lens laboratories;  
equipment, accessories, tools, machinery a nd instruments;  maintenance and services;  
storage and distribution;  handling of input materials; packaging;  quality management;  
quality control;  documentation and records. 
 
7. Objective and rationale, including the nature of urgent problems where applicable:  
 Protection of human life and health. G/TBT/N/COL/108 
Page 2  
 
  8. Relevant documents:   Law No. 594 of 2000, Decree No. 2676 of 22 December 2000, 
Decree No. 1030 of 30 March 2007 and Resolution No. 1164 of 6 September 2002 of the Ministry of the Environment and the Ministry of Health. 
9. Proposed date of adoption: 
Proposed date of entry into force:  Date on which the Resolution is signed. 
Six months after the date of publication in the Official Journal. 
10. Final date for comments:   20 May 2008 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, E-mail and website addresses,  if available, of other body:  
Contact person:  Daniel Héctor Rico R. 
 
E-mail: drico@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, tercer piso Bogotá, D.C., Colombia  
Tel.: (+571) 241 0478 
Web site: http://secgen.comunidadandina.org/sirt  Ministerio de la Protección Social Dirección General de Calidad de Servicios Grupo de Medicamentos e Insumos 
Carrera 13 No. 32 – 76 
Bogotá, D. C., Colombia 
 
Tel.: (+571) 330 5000, Ext. 1860 to 1865 Fax: (+571) 336 0182  E-mail: mcrodriguez@minproteccionsocial.gov.co
 
Web site: http://www.minproteccionsocial.gov.co