G/TBT/N/ECU/325/Add.3  
17 November  2023 
(23-7753) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 1 7 November 2 023, is being circulated at the request of the 
delegation of Ecuador . 
 
_______________  
 
 
Title: REFORMA PARCIAL A LA NORMATIVA TÉCNICA SANITARIA SUSTITUTIVA  PARA EL REGISTRO 
SANITARIO Y CONTROL DE DISPOSITIVOS MÉDICOS DE USO HUMANO, Y DE LOS 
ESTABLECIMIENTOS EN DONDE SE FABRICAN, IMPORTAN, DISPENSAN, EXPENDEN Y 
COMERCIALIZAN  (Partial amendment to the Substitute Sanitary Technical Regulation on the sanitary 
registration and control of medical devices for human use and of the establishments that 
manufacture, import, dispense, sell or market such devices)  
 
Reason for Addendum:  
[ ] Comment period changed - date:  
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[X] Notified measure enters into force - date: 10 November 2 023 
[X] Text of final measure available from1: 
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2023/TBT/ECU/final_measure/23_13482_0
0_s.pdf  
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:  
[ ] Content or scope of notified measure changed and text available from1: 
New deadline for comments (if applicable):  
[ ] Interpretive guidance issued and text availabl e from1: 
[ ] Other:  
 
 
1 This information can be provided by including a website address, a PDF attachment, or other 
information on where the text of the final measure/change to the measure/interpretative guidance can be 
obtained.  G/TBT/N/ECU/325/Add.3  
- 2 - 
  Description : The notified text partially amends the Substitute Sanitary Technical Regulation on the 
sanitary registration and control of medical devices for human use and of the establishments that 
manufacture, import, dispense, sell or market such devices.  
By means of this Addendum No. 3, the Republic of Ecuador advises that the Partial amendment to 
the Substitute Sanitary Technical Regulation on the sanitary registration and control of medical 
devices for human use and  of the establishments that manufacture, import, dispense, sell or market 
such devices has been issued pursuant to Resolution No. A RCSA -DE-2023-033-AKRG of 1 0 
November 2 023 of the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, 
Doctor Leopoldo Izquieta Pérez) . The Regulation will enter into force on the date of its signature, 
without prejudice to its publication in the Official Journal.  
Text available from : Ministerio de Producción, Comercio Exterior, Inversiones y Pesca  (Ministry of 
Production, Foreign Trade, Investment and Fisheries), Subsecretaría de Calidad  (Under -Secretariat 
for Quality), Organismo Nacional de Notificación  (National Notification Authority):  
TBT enquiry point : Eduardo Yépez  
Plataforma Gubernamental de Gestión Fi nanciera - Piso 8 Bloque amarillo Av . Amazonas entre Unión 
Nacional de Periodistas y Alfonso Pereira  
Quito, Ecuador  
Tel.: (+593 -2) 3948760, Ext. 2252/2254  
Email:  
Puntocontacto -OTCECU@produccion.gob.ec  
cyepez@produccion.gob.ec  
__________