Overview of the proposed regulations for medical devices and IVDs in Nicaragua
£45.00
Prepare for success in Nicaragua by understanding the latest regulatory proposals for medical devices and IVDs, a key resource for market entry
English
Mandatory Nicaraguan Technical Standard NTON 24001:2023, Health technology. Medical devices. Requirements for Health Registration, was approved by the Technical Committee for Standardization on 31 October 2023. The purpose of this standard is to establish the requirements and provisions for granting health registrations for medical devices for human use. This standard applies to natural or legal persons that manufacture, enhance, reprocess, resterilise or import medical devices for distribution and market placement. The proposed date of adoption and entry into force are still to be determined. This article summarises the standard and includes the definition of a medical device and an in vitro diagnostic, the submission requirements and procedure for obtaining a health registration (marketing authorisation), registration renewals, and post-market changes.
Specification: 16 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the May 2024 issue of the Journal of Medical Device Regulation.
