G/TBT/N/CHL/598  
17 June 2022 
(22-4727) 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, MINSAL - Subsecretaría de Salud Pública (Ministry of Health, Under -
Secretariat for Public 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:  
Subsecretaría de Relaciones Económicas Internacionales, SUBREI  - Ministerio de 
Relaciones Exteriores de Chile (Under -Secretariat for International Economic Relations, 
Ministry of Foreign Affairs of Chile)  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], 
other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : Medical 
devices to detect Human Immunodeficiency Virus (HIV)  
5. Title, number of pages and language(s) of the notified document : Decreto Exento 
N° 41 del Ministerio de Salud, de fecha 08 de junio de 2022 : Incorpora al régimen de 
control sanitario establecido en el artículo 111 del Código Sanitario, a los dispositivos para 
detección de VIH que indica  (Ministry of Health Exempt Decree No. 41 of 8 June 2 022 
adding the indicated devices for HIV detection to the health control syste m established in 
Article 111 of the Health Code) (3 pages, in Spanish)  
6. Description of content : Ministry of Health Exempt Decree No. 41 of 2022 provides for 
the inclusion of the indicated devices for HIV detection in the health control system in 
Chile, which is governed by the provisions of Ministry of Health Supreme Decree No. 825 
of 1998 approving the regulations on the control of products and goods for medical use . 
The health control involves various activities aimed at verifying that the devices meet 
certain technical specifications, which are listed in the notified Decree, in order to ensure 
their quality and guarantee that they function  properly.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health or safety  G/TBT/N/CHL/598  
- 2 - 
  8. Relevant documents:  
Ministry of Health Supreme Decree No. 825 of 1998 approving the regulations on the 
control of products and goods for medical use : 
https://www.bcn.cl/leychile/navegar?idNorma=141005  
Health Code : 
https://www.bcn.cl/leychile/navegar?i=5595&f=1968 -01-31 
9. Proposed date of adoption : 8 June 2 022 
Proposed date of entry into force : 16 December 2 022 
10. Final date for comments : 60 days from notification  
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Subsecretaría de Relaciones Económicas Internacionales - Ministerio de Relaciones 
Exteriores de Chile  
Teatinos 180, piso 11  
Tel.: (+56) 2 2827 5250  
Fax: (+56) 2 2380 9494  
Email: tbt_Chile@subrei.gob.cl  
https://www.minsal.cl/wp -content/uploads/2021/11/D -Ex-41-2022-Somete -a-control -
ensayos -VIH-incluye -autotest -D-Of-16-06-2022.pdf ) 
https://members.wto.org/crnattachme nts/2022/TBT/CHL/22_4168_00_s.pdf