By: Guiselle Téllez
The agreed definition of the term “Medical Device” is any instrument, apparatus, implement, machine, device, implant, material, or other similar or related article used alone or in combination, including accessories and software necessary for its correct application proposed by the manufacturer in its use with human beings, intended for the diagnosis, prevention, monitoring, treatment and alleviation of diseases, damage or disability.
Medical Devices in Nicaragua must comply with the requirements established by the Ministry of Health for their authorization to safeguard the health of people.
These requirements must be applied throughout the national territory and must be complied with by the persons who produce, process, pack, package, label, store, sell, import, export, commercialize, or maintain medical devices, as well as by the legal representatives, national and foreign, and also for the representatives of the health service provider establishments in which medical devices are available.
The fulfillment of all the requirements to obtain the sanitary registration of your medical device will depend on the category in which the medical device is classified according to its risk.
We provide below a general summary of the requirements (legal and technical) for the registration of medical devices in Nicaragua, and we remind you that we are here to answer your questions regarding this process.
