. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/COL/99 
6 June 2005 
 (05-2310) 
Committee on Sanitary a nd Phytosanitary Measures Original:   Spanish 
  
 
NOTIFICATION 
 
1. Member to Agreement notifying:   COLOMBIA
 
If applicable, name of local government involved:  
2. Agency responsible:  Ministry of Social Welfare 
3. Products covered (provide tariff item number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Medical devices and biomedical equipment 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
 Trading partners of Colombia. 
5. Title, language and number of pa ges of the notified document:  Draft Decree 
"Regulating the sanitary registration, marketi ng 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 registra tion system; marketing approval; general 
requirements for computer-controlled biomedical  equipment; importation of raw materials; 
general provisions governing labelling, packag ing and labelling inform ation; control and 
surveillance; information pertaining to ma rket withdrawal; traceability; sampling; and 
sanitary measures. 
7. Objective and rationale:  [   ] food safety, [   ] animal health, [   ] plant protection,   
[ X ] protect humans from animal/plant pest or disease, [   ] protect territory from 
other damage from pests  
8. International standard, gu ideline or recommendation:  
[   ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE),  [   ] International Plant Protection Convention,  [X] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:    
9. Relevant documents and language(s) in which these are available:   Law 09 of 1979, 
Article 245 of Law 100 of 1993, and Article 42.3 of Law 715 of 2001. 
10. Proposed date of adoption:   Upon publication in the Official Journal. 
11. Proposed date of entry into force:   Six (6) months as from the date of publication in the 
Official Journal. 
 G/SPS/N/COL/99 
Page 2  
 
 12. Final date for comments:   1 September 2005 
Agency or authority designated to handle comments:  [  X ] National notification 
authority, [  X ] National enquiry point, or address, fax number and E-mail address 
(if available) of other body:  
Servicio Nacional de Información (National Enquiry Point): 
Ministerio de Comercio, Industria y Turismo 
Dirección de Regulación 
Calle 28 No. 13A - 15, cuarto piso Bogotá, D.C., Colombia Tel.: (571) 606-7676, Ext. 1690 Fax: (571) 241-0478 
or 
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 
Website: www.minsalud.gov.co 
13. Texts available from:  [ X ] National notification authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
Ministerio de Comercio, Industria y Turismo 
Dirección de Regulación 
Calle 28 No. 13A - 15, cuarto piso  Bogotá, D.C., Colombia Enquiry Point
:  
Contact person :  Daniel Héctor Rico R.  
E-mail: danielrico@mincomercio.gov.co 
Tel.: (571) 606-7676, Ext. 1690 Fax: (571) 241-0480 Website: http://www.mincomercio.gov.co