G/TBT/N/CHL/666  
14 December  2023 
(23-8559) 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 (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:  
Subsecretaría de Relaciones Económicas Internacionales (SUBREI) - Ministerio de 
Relaciones Exteriores de Chile (Under -Secretariat for International Economic Relations, 
Ministry of Foreign Affairs)  
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) : Sterile 
hypodermi c needles for single use and sterile hypodermic syringes for single use  
5. Title, number of pages and language(s) of the notified document : Actualiza 
Normas asociadas al régimen de control establecido en el artículo 111 del Código 
Sanitario, para agujas h ipodérmicas estériles para un solo uso y jeringas, con las mismas 
condiciones, según indica  (Updated standards on the health control system established in 
Article  111 of the Health Code for sterile, single -use, hypodermic needles and syringes, 
as indicated ) (4 pages, in Spanish)  
6. Description of content : The notified text updates the standards for sanitary control and 
verification of the conformity of hypodermic, sterile and single -use needles and syringes, 
as previously established in Ministry of Health Exempt Decree No.  1887 of 27  December  
2007, issued for the incorporation into the control system established by Article  111 of 
the Sanitary Code and its implementing Regulations approved by Ministry of Health 
Decree No.  825 of 1998 of the medical devices indicated.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health or safety  G/TBT/N/CHL/666  
- 2 - 
  8. Relevant documents:  
Chilean Health Code ( Código Sanitario ) 
Ministry of Health Supreme Decree No. 825/1998 approving the Regulations on the 
control of products and goods for medical use (Medical Devices).  
Ministry of Health Exempt Decree No. 1887 of 2 7 December 2 007. 
Chilean Standard NCh2503:2021 : Agujas Hipodérmic as estériles para un solo uso - 
Requisitos y métodos de ensayo.  
Chilean Standard NCh2504/1:2021 : Jeringas hipodérmicas estériles para un solo uso - 
Parte 1 : Jeringas de uso manual.  
9. Proposed date of adoption : - 
Proposed date of entry into force : - 
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 (SUBREI) - Ministerio de 
Relaciones Exteriores de Chile  
Teatinos 180, piso 11  
Tel.: (+56) 2 2827 525 0 
Email: tbt_chile@subrei.gob.cl  
https://www.minsal.cl/wp -content/uploads/2021/11/Decreto -actualiza -Normas -
Jeringas -y-Agujas-Rev.-29112023 -para-Consulta -Publica -V-29112023.pdf  
https://members.wto.org/crnattachments/2023/TBT/CHL/23_14516_00_s.pdf