G/TBT/N/SLV/228  
19 July 2023 
(23-4909) 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 : EL SALVADOR  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Organismo Salvadoreño de Reglamentación Técnica , OSARTEC (Salvadoran Technical 
Regulation Agency)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regardi ng the notification shall be indicated if different from above:  
Ministerio de Economía  (Ministry of the Econom y) 
Dirección de Administración de Tratados Comerciales  (Directorate for the Administration 
of Trade Agreements)  
Alameda Juan Pablo II y Calle Guadalupe, Plan Maestro, San Salvador, El Salvador  
Website: http://www.economia.minec.gob.sv  
Tel.: (+503) 2590 5788 ; Fax: (+503) 2590 5789  
Email: datco@economia.gob.sv  
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 (ICS code : 11.140)  
5. Title, number of pages and language(s) of the notified document : Reglamento 
Técnico Salvadoreño -RTS- 11.03.04:23 VIGILANCIA POSTCOMERCIALIZACIÓN DE 
DISPOSITIVOS MÉDICOS . TECNOVIGILANCIA  (Salvadoran Technical Regulation (RTS)  
No. 11.03.04:23 : Post-marketing monitoring of medical devices . Technological 
monitoring) (15 pages, in Spanish)  
6. Description of content : The notified Salvadoran Technical Regulation establishes the 
technical provisions for the development and implement ation of technological monitoring 
at the national level, in accordance with the existing legal framework and the relevant 
internationally harmonized principles, which allow for the identification, registration, 
assessment, follow -up and dissemination of in formation on the adverse events and 
incidents caused by the breakdown of  a medical device, in addition to any quality 
irregularities and breaches of the existing health laws applicable to these health 
technologies.  
It applies to institutions providing priv ate health services and to those within the 
Integrated National Health System, in addition to sanitary registration holders, 
manufacturers, packagers, storage centres, importers, exporters and distributors of 
medical devices at the national level, whether or not for marketing purposes.  G/TBT/N/SLV/228  
- 2 - 
  7. Objective and rationale, including the nature of urgent problems where 
applicable : Prevention of deceptive practices and consumer protection ; Protection of 
human health or safety  
8. Relevant documents:  
• RTS 11 .03.02:21 DISPOSITIVOS MÉDICOS REQUISITOS PARA LA REGULACIÓN 
SANITARIA DE DISPOSITIVOS MEDICOS . 
• RTS 11 .03.03:22 DISPOSITIVOS MÉDICOS BUENAS PRÁCTICAS DE 
MANUFACTURA DE DISPOSITIVOS MÉDICOS Y SU GUÍA DE VERIFICACIÓN . 
9. Proposed date of adoption : To be det ermined  
Proposed date of entry into force : Six months after publication in the Official Journal  
10. Final date for comments : 60 days from notification  
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Ministerio de Economía  
Dirección de Administración de Tratados Comerciales  
Alameda Juan Pablo II y Calle Guadalupe, Plan Maestro, San Salvador, El Salvador  
Website: http://www.economiaminec.gob.sv  
Tel.: (+503) 2590 5788 ; Fax: (+503) 2590 5789  
Email: datco@economia.gob.sv  
Consejo Nacional de Calidad  (National Quality Council)  
Organismo Salvadoreño de Reglamentación Técnica (OSARTEC)  
Boulevard San Bartolo y Calle Lempa, costado Norte del INSAFORP, Edificio CNC, 
Ilopango, San Salvador, El Salvador  
Websit e: http://www.osartec.gob.sv  
Tel.: (+503) 2590 5335 ; (+503) 2590 5338  
Email: consultasreglamento@osartec.gob.sv  
https://members.wto.org/crnattachments/2023/TBT/SLV/23_10990_00_s.pdf