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 agency 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, 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

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, Health 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:

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Final date for comments: 20 January 2024

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://members.wto.org/crnattachments/2023/TBT/NIC/23_13458_00_s.pdf