G/TBT/N/SLV/218  
18 November  2021 
(21-8698) 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 
regarding the notification shall be indicated if different from above:  
Ministerio de Economía (Ministry of the Economy)  
Dirección de Administración de Tratados Comerciales  (Directorate for the Administration 
of Trade Agreements)  
Alameda Juan Pablo II y Cal le Guadalupe, Plan Maestro, San Salvador, El Salvador  
Website: http://www.economia.gob.sv  
Tel.: (+503) 2590 5788  
Email: datco@economia.gob.sv  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 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) : Hospital 
equipment ( ICS 11 .140)  
5. Title, number of pages and language(s) of the notified document : Reglamento 
Técnico Salvadoreño RTS 11 .03.02:21 DISPOSITIVOS MÉDICOS . REQUISITOS PARA LA 
REGULACIÓN SANITARIA DE DISPOSITIVOS MÉDICOS  (Salvadoran Technical Regulation 
RTS 11 .03.02:21 : Medical devices . Requirements for the sanitary regulation of medical 
devices) (21 pages, in Spanish)  
6. Description of content : The notified Regulation establishes the technical provisions 
governing the sanitary regulation of medical devices in El Salvador, on  the basis of the 
existing legal framework and the internationally harmonized principles of good regulatory 
practice.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Prevention of deceptive practices and consumer prot ection ; Protection of 
human health or safety  
8. Relevant documents:  
• ISO 15223 -1:2021 : Medical devices . Symbols to be used with information to be 
supplied by the manufacturer . Part 1: General requirements  
• Ley de Medicamentos . Dirección Nacional de Medicamentos . Decreto Legislativo 
No 1008, Diario Oficial No. 43, Tomo No. 394 del 2 de marzo de 2012 . El 
Salvador.  G/TBT/N/SLV/218  
- 2 - 
  • Reglamento General de la Ley de Medicamentos . Dirección Nacional de 
Medicamentos . Decreto Legislativo No. 245, Diario Oficial No. 239, Tomo No. 
397 del 20 de diciembre de 2012 . El Salvador.  
• RTS Insumos Médicos . Mascarillas de Uso Médico . Especificaciones Técnicas y 
Métodos de Ensayo  (current version)  
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : To be determined  
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.economia.gob.sv  
Tel.: (+503) 2590 5788  
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  
Website: http://www.osartec.gob.sv  
Tel.: (+503) 2590 5335 ; (+503) 2590 5338  
Email: consultasreglamento@osartec.gob.sv  
 
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