WTO notification · TBT
NicaraguaUpdated: check whether it is now adopted or in force
NTON 24001:2023 Health technology. Medical devices. Requirements for Sanitary Registration (Nicaraguan Mandatory Technical Standard (NTON) No. 24001:2023)
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)
Nicaragua issued an addendum on 1 June 2026 to the earlier TBT notification G/TBT/N/NIC/178. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 15 November 2023. The comment period closed on 20 January 2024.
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Medical equipment
The comment period closed on 20 January 2024. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/NIC/178/Add.1; it can take them up with Nicaragua.
Find your country's enquiry point on WTO ePing (opens in a new tab)Latest notice (G/TBT/N/NIC/178/Add.1, 1 June 2026)
Nicaraguan Mandatory Technical Standard (NTON) No. 24001: Health technology. Medical devices. Health registration requirements
On 15 November 2023, the Government of the Republic of Nicaragua notified, in document G/TBT/N/NIC/178, draft Nicaraguan Mandatory Technical Standard (NTON) No. 24001:2023: Health technology. Medical devices. Health registration requirements. The draft text sought to establish the requirements and provisions for the health registration of medical devices for human use. The Standard applies to natural or legal persons who manufacture, refurbish, reprocess, resterilize, or import medical devices for distribution and marketing.WTO Members are hereby informed that the previously notified Technical Regulation has been updated by Addendum No. 2026-05, and accordingly a period of 30 days from the notification date is granted for the submission of comments and observations.__________1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final/modified measure and/or interpretative guidance can be obtained.
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.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/NIC/178/Add.1
Nicaraguan Mandatory Technical Standard (NTON) No. 24001: Health technology. Medical devices. Health registration requirements
On 15 November 2023, the Government of the Republic of Nicaragua notified, in document G/TBT/N/NIC/178, draft Nicaraguan Mandatory Technical Standard (NTON) No. 24001:2023: Health technology. Medical devices. Health registration requirements. The draft text sought to establish the requirements and provisions for the health registration of medical devices for human use. The Standard applies to natural or legal persons who manufacture, refurbish, reprocess, resterilize, or import medical devices for distribution and marketing.WTO Members are hereby informed that the previously notified Technical Regulation has been updated by Addendum No. 2026-05, and accordingly a period of 30 days from the notification date is granted for the submission of comments and observations.__________1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final/modified measure and/or interpretative guidance can be obtained.
Regular notificationG/TBT/N/NIC/178
Comment deadline: Closed on 20 January 2024
NTON 24001:2023 Health technology. Medical devices. Requirements for Sanitary Registration (Nicaraguan Mandatory Technical Standard (NTON) No. 24001:2023)
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)
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.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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