G/TBT/N/NIC/178  
15 November  2023 
(23-7705) 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 : NICARAGUA  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Autoridad Nacional de Regulación Sanitaria , ANRS (National Health Regulatory 
Authority)/ Dirección de Dispositivos Médicos  (Medical Device Directorate)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agen cy or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  
Ministerio de Fomento, Industria y Comercio , MIFIC  (Ministry of Development, Industry 
and Trade)  
Dirección de Normalización y Metrología , DNM (Directorate of Standardization and 
Metrology)  
Oficina de Información y Notificación , OIN (Information and Notification Office)  
Carretera a Masaya, Kilómetro 6, fre nte a Camino de Oriente . Managua, Nicaragua  
Tel.: (+505) 2248 9300, Ext. 1320 ; 1314; 1310 
Email: imartinez@mific.gob.ni ; notificacio n@mific.gob.ni ; normalizacion@mific.gob.ni ; 
Website : www.mific.gob.ni/Inicio/Comercio/Comercio -Interior/SNC/snn/enn/ncp  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], 
other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : Medical 
equipment  (ICS code : 11.040)  
5. Title, number of pages and language(s) of the notified document : NTON 
24001 :2023 Tecnología de la salud . Dispositivos médicos . Requisitos para el Registro 
Sanitario  (Nicaraguan Mandatory Technical Standard (NTON) No. 24001:2023, Hea lth 
technology . Medical devices . Sanitary registration requirements)  
6. Description of content : The notified Standard establishes the requirements and 
provisions for the sanitary registration of medical devices for human use . The Standard 
applies to natural or legal persons that manufacture, refurbish, reprocess, resterilize or 
import medical devices for distribution and marketing.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health or safety  
8. Relevant documents:  
 G/TBT/N/NIC/178  
- 2 - 
  9. Proposed date of adoption : To be determined  
Proposed date of entry into force : To be determined  
10. Final date for comments : 20 January 2 024 
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 Fomento, Industria y Comercio , MIFIC (Ministry of Development, Industry 
and Trade)  
Dirección de Normalización y Metrología , DNM ( Directorate of Standardization and 
Metrology)  
Oficina de Información y Notificación , OIN (Information and Notification Office)  
Carretera a Masaya, Kilómetro 6, frente a Camino de Oriente . Managua, Nicaragua  
Tel.: (+505) 2248 9300, Ext. 1320 ; 1314; 1310 
Email: imartinez@mific.gob.ni ; notificacion@mific.gob.ni ; normalizacion@mific.gob.ni ; 
Website : www.mific.gob.ni/Inicio/Comercio/Comercio -Interior/SNC/snn/enn/ncp  
https://www.mific.gob.ni/Inicio/Comercio/Comercio -Interior/SNC/snn/enn/ncp  
https://members.wto.org/crnattachments/2023/TBT/NIC/23_13458_00_s.pdf