G/TBT/N/HND/94  
2 April 2019  
(19-2041) 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 : HONDURAS  
If applicable, name of local government involved (Articles 3.2 and 7.2):   
2. Agency responsible : Secretaría de Desarrollo Económico , SDE (Secretariat for Economic 
Development)  
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:  
Dirección General de Integración Económica y Política Comercial  (Directorate -General of 
Economic Integration and Trade Policy)  
Boulevard José Cecilio del Valle  
Edificio San José, 3er piso  
Fax: (+504) 2235 -8383 or 2235 -5047 
Email: gsalinas_sic@yahoo.com   
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) : 
ICS 11.120.01  
5. Title, number of pages and language(s) of the notified document : Reglamento 
para el Control de Establecimientos y Dispositivos Médicos y Otros Dispositivos de Interés 
Sanitario  (Regulations on the control of medical devices and other devices of sanitary 
interest and related establishments) (47 pages, in Spanish)  
6. Description of content : The notified Regulations establish provis ions on sanitary 
regulation, control and promotion to be met by natural and legal persons . Under these 
provisions, sanitary authorization shall be granted in respect of services and 
establishments relating to the manufacture, upgrading, packaging, importat ion, 
exportation, storage, transportation, distribution, marketing, rental, leas ing, maintenance 
and advertising of, and research into, medical devices and other devices of sanitary 
interest.  
The provisions apply to natural and legal persons that manufactu re, upgrade, package, 
import, export, store, transport, distribute, market , rent out, lease or research these 
products, that provide maintenance or advertising services in this respect, or that are 
engaged in any other activity involving medical devices an d other devices of sanitary 
interest , and to establishments involved in any activity related thereto, within national 
territory.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human life and health.  G/TBT/N/HND/94  
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  8. Relevant documents:  
- 
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 the date of 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:  
Agencia de Regulación Sanitaria , ARSA (Agency for Sanitary Regulation)  
Dirección de Alimentos y Bebidas  (Food and Beverage Directorate)  
Calle Los Alcaldes, Frente al City Mall  
Email: consultapublica@arsa.gob.hn  
Website: http://www.arsa.gob.hn/  
Secretaría de Desarrollo Económico  (Secretariat for Economic Development)  
Dirección General de Integración Económica y Política Comercial  (Directorate -General of 
Economic Integration and Trade Policy)  
Boulevard José Cecilio del Valle  
Edificio San José, 3er piso  
Fax: (+504) 2235 -8383 or 2235 -5047 
Email:  
gsalinas_sic@yahoo.com  
wenrodsar@gmail.com  
Website: https://sde.gob.hn/wp -content/uploads/2019/03/BORRADOR -REGLAMENTO -
DISPOSITIVOS -MEDICOS -ULTIMA -VERSI%C3%93N -15-mar-2019.pdf