G/TBT/N/SLV/219  
31 January  2022 
(22-0743) 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 Comer ciales  (Directorate for the Administration 
of Trade Agreements)  
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  
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 b e 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 .03.03:22 : Dispositivos Médicos . Buenas Prácticas de 
Manufactura de Dispositivos Médicos y Su Guía de Verificación  (Salvadoran Technical 
Regulation RTS 11 .03.03:22 : Medical devices . Good manufacturing practices for medical 
devices and verification manual) (89 pages, in Spanish)  
6. Description of content : The notified Regu lation establishes the principles and guidelines 
for good manufacturing practices that regulate all procedures involved in the manufacture 
of medical devices, in order to ensure the effectiveness, safety and quality of such items.  
7. Objective and rationa le, including the nature of urgent problems where 
applicable : Prevention of deceptive practices and consumer protection ; Protection of 
human health or safety  
8. Relevant documents:  
• ISO 13485: M edical devices - Quality management systems - Requirements for 
regulatory purposes  
• ISO 14971: M edical devices - Application of risk management to medical 
devices  G/TBT/N/SLV/219  
- 2 - 
  • 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.  
• Mexican Official Standard NOM -241-SSA1 -2021: Buenas Prácticas de 
Fabricación de Dispositivos Médicos.  
• 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.  
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 Economí a 
Dirección de Administración de Tratados Comerciales  
Alameda Juan Pablo II y Calle Guadalup e, 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  
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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