G/TBT/N/CHL/455  
14 August  2018 
(18-5144) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : CHILE 
If applicable, name of local government involved (Articles 3.2 and 7.2):   
2. Agency responsible : Ministerio de Salud  (Ministry of Health)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  
Dirección General de Relaciones Económicas Internacionales  - Ministerio de Relaciones 
Exteriores  (Directorate -General of International Economic Relations, Ministry of Foreign 
Affairs)  
3. Notified under Article 2.9.2 [ ], 2.10.1 [X], 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) : Condoms - 
Natural rubber latex male  condoms, male synthetic condoms, female condoms  
5. Title, number of pages and language(s) of the notified document : Incorpora los 
productos que indica al régimen de control sanitario establecido en el Artículo 111 del 
Código Sanitario y en el Decreto Sup remo N° 825 de 1998 del Ministerio de Salud  
(Incorporation of the indicated products into the health control system established in 
Article 111 of the Health Code and in Ministry of Health Supreme Decree No. 825 de 1998) 
(3 pages, in Spanish)  
6. Descripti on of content : The notified text incorporates the indicated products for medical 
use into the health system established in Article 111 of the Health Code and the 
regulations thereto, approved by Ministry of Health Supreme Decree No. 825. The 
conformity of such products must be verified in accordance with the following technical 
standards and specifications:  
Preservativos - Condones Masculinos de Látex de Caucho Natural : Norma ISO -UNE EN 
4074: 2016, Clase III  (Condoms - Natural rubber latex male condoms : Standard ISO -UNE 
EN 4074 : 2016, Class III);  
ISO 23409:2011, Male condoms - Requirements and test methods for condoms made from 
synthetic materials, Class III;  
ISO 25841:2017, Female condoms - Requirements and test methods, Class III.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Health protection  G/TBT/N/CHL/455  
- 2 - 
  8. Relevant documents:  
 Código Sanitario ; 
 Decreto con Fuerza de Ley N° 1 de 2005 del Ministerio de Salud ; 
 Decreto Supremo n° 825 de 1998 del Ministerio de Salud ; 
 Norma ISO-UNE EN 4074 : 2016, Clase III ; 
 ISO 23409:2011, Male condoms - Requirements and test methods for condoms 
made from synthetic materials, Class III;  
 ISO 25841:2017, Female condoms - Requirements and test methods, Class III.  
9. Proposed date of adoption : 24 July 2 018 
Proposed date of entry into force : 31 December 2 018 
10. Final date for comments : 60 days from the date of notification  
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses , if available, of other body:  
Departamento Regulatorio  (Regulations Department)  
Dirección General de Relaciones Económicas Internacionales  (Directorate -General of 
International Economic Relations)  
Ministerio de Relaciones Exteriores  (Ministry of Foreign Affairs)  
Teatinos 180, piso 11  
Tel.: (+56) 2 -2827 5250  
Fax: (+56) 2 -2380 9494  
Email: Tbt_Chile@direcon.gob.cl  
http://www.minsal.cl/wp -content/uploads/2018/08/DS -MINSAL -Nº-93-2018-
Preservativos.pdf  
https://members.wto.org/crnattach ments/2018/TBT/CHL/18_4395_00_s.pdf