Medical equipment (ICS code: 11.040)

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.