G/TBT/N/ECU/325  
3 May 2016  
(16-2486)  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: ECUADOR 
If applicable, name of local governme nt involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Agencia Nacional de Regulacion, Control y Vigilancia Sanitario,  ARCSA (National Agency for 
Sanitary Regulation, Control and Surveillance) Ciudadela Samanes, Av. Francisco de Ore llana y Av. Paseo del Parque. Bloque 5 
Tel./Fax: (+593-4) 3727 440 
Email: PuntocontactoOTCECU@mipro.gob.ec  
Website: http://www.normalizacion.gob.ec/  
Name and address (including telephon e 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 la Calidad (Under-Secretariat for Quality) 
Ministerio de Industrias y Productividad , MIPRO (Ministry of Industry and Productivity) 
Address: Yánez Pinzón N26-12, entre Av. Colón y La Niña Quito, Ecuador Tel.: (+593-2) 3948 760, Ext. 2358 or 2253 
Email: PuntocontactoOTCECU@mipro.gob.ec , mmartinez@mipro.gob.ec  
Website: http://www.industrias.gob.ec/  
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): 
9.018.90.10 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
Normativa técnica sanitaria para el registro sanitario y control de dispositivos médicos de 
uso humano, y de los establecimientos en donde se fabrican, almacenan, distribuyen y 
comercializan  (Draft Sanitary Technical Regulation on the sanitary registration and control 
of medical devices for human use, and of the establishments that manufacture, store, 
distribute or market such devices) (25 pages, in Spanish) 
6. Description of content: The notified draft Technical Regulation covers the following: 
Purpose and scope; Definitions and abbreviations; Sanitary registration of medical devices 
for human use; Obtaining sanitary registration; Packaging, labelling and inserts/user manuals; Re-registration and changes to the sanitary registration of medical devices for 
human use; Other authorizations; Importation; Marketing and promotion; Operating 
permits for pharmaceutical establishments relating to medical devices for human use; Monitoring and control; and Penalties. G/TBT/N/ECU/325 
- 2 - 
  7. Objective and rationale, including the nature of urgent problems where 
applicable: The notified Sanitary Technical Regulation establishes the parameters of 
quality, safety and effectiveness for the sanitary registration of medical devices for human 
use, and the criteria for the promotion, control and monitoring of, and penalties regarding such products. 
It also establishes the parameters for the operation, control and monitoring of 
establishments that manufacture, store, distribute or market medical devices for human 
use. 
Its application is mandatory for natural and legal persons responsible for manufacturing, 
assembling, importing, exporting, storing, distributing or marketing medical devices for 
human use within the national territory. 
8. Relevant documents:  
1. Publication where notice appears: http://www.industrias.gob.ec/ , 
http://www.industrias.gob.ec/ , 
http://www.controlsanitario.gob.ec/ http://www.controlsanitario.gob.ec/  
2. Proposal and basic document: Proyecto de Normativa técnica sanitaria para el 
registro sanitario y control de dispositivos médicos de uso humano, y de los 
establecimientos en donde se fabrican, almacenan, distribuyen y comercializan  
(Draft Sanitary Technical Regulation on the sanitary registration and control of medical devices for human use, and of the establishments that manufacture, store, distribute and market such devices) 
3. Publication in which Technical Regulation will be published when adopted: Registro 
Oficial  (Official Journal). 
9. Proposed date of adoption: 90 days from 29 April 2016. 
Proposed date of entry into force: 180 days from date of adoption.  
10. Final date for comments: 28 July 2016 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresse s, if available, of other body:  
Contact and/or National Enquiry Point: 
Marlon Martínez 
Subsecretaría de la Calidad Ministerio de Industrias y Productividad, MIPRO 
Address: Yánez Pinzón N26-12, entre Av. Colón y La Niña 
Quito, Ecuador Tel.: (+593-2) 3948 760, Ext. 2358 or 2253 Email: PuntocontactoOTCECU@mipro.gob.ec , mmartinez@mipro.gob.ec  
Website: http://www.industrias.gob.ec/