G/TBT/N/ECU/238  
25 April 2014  
(14-2548)  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:  
Instituto Ecuatoriano de Normalización, INEN (Ecuadorian Standardization Institute) 
Calle Baquerizo Moreno E8-29 y Diego de Almagro Tel.: +593 2 250-1885 Fax: +593 2 256-7815 
Email: PuntocontactoOTCECU@mipro.gob.ec  
Website: http://www.inen.gob.ec/  
Name and address (including telephone and fax numbers and 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) 
Yánez Pinzón N26-12, entre Av. Colón y La Niña Quito, Ecuador Tel.: +593 2 394-8760, Ext. 2358 or 2253 
Email: aanrango@mipro.gob.ec ; mmartinez@mipro.gob.ec ; 
PuntocontactoOTCECU@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): 
9018.90.10 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
PRTE INEN 186, "Equipos Electromédicos"  (Draft Technical Regulation of the Ecuadorian 
Standardization Institute (PRTE INEN) No. 186: "Electro-medical equipment") (6 pages, in Spanish)  
6. Description of content: The notified draft Technical Regulation covers the following: 
Purpose; Scope; Definitions; Product requirements; Labelling requirements; Sampling; 
Conformity assessment tests; Reference documents; Conformity assessment procedure; 
Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. G/TBT/N/ECU/238 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: The notified Technical Regulation establishes general requirements for the 
basic safety, essential performance and electr omagnetic compatibility of electro-medical 
equipment and systems, with a view to protec ting human life and safety and preventing 
practices likely to mislead or confuse users. It applies to domestically manufactured or imported electro-medical equipment and systems marketed in Ecuador. 
8. Relevant documents:  
1. Publication where notice appears:  http://www.industrias.gob.ec/, 
 http://www.inen.gob.ec/ ; 
2. Proposal and basic document: Proyecto de PRTE INEN 186, "Equipos 
Electromédicos"  (Draft Technical Regulation of the Ecuadorian Standardization Institute 
(PRTE INEN) No. 186: "Electro-medical equipment"); 
3. Publication in which Technical Regulation will be published when adopted: Registro 
Oficial  (Official Journal). 
9. Proposed date of adoption: 
Proposed date of entry into force:   90 days from 7 April 2014.  
Three months after adoption.  
10. Final date for comments: 6 July 2014 
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: 
Subsecretaría de la Calidad 
Ministerio de Industrias y Productividad, MIPRO 
Yánez Pinzón N26-12, entre Av. Colón y La Niña 
Quito, Ecuador Tel.: +593 2 394-8760, Ext. 2358 or 2253 Email: aanrango@mipro.gob.ec ; mmartinez@mipro.gob.ec ; 
PuntocontactoOTCECU@mipro.gob.ec  
Website: http://www.industrias.gob.ec/