ICS 11.120.01

Reglamento para el Control de Establecimientos y Dispositivos Médicos y Otros Dispositivos de Interés Sanitario (Regulations on the control of medical devices and other devices of sanitary interest and related establishments) (47 pages, in Spanish)

The notified Regulations establish provisions on sanitary regulation, control and promotion to be met by natural and legal persons. Under these provisions, sanitary authorization shall be granted in respect of services and establishments relating to the manufacture, upgrading, packaging, importation, exportation, storage, transportation, distribution, marketing, rental, leasing, maintenance and advertising of, and research into, medical devices and other devices of sanitary interest. The provisions apply to natural and legal persons that manufacture, upgrade, package, import, export, store, transport, distribute, market, rent out, lease or research these products, that provide maintenance or advertising services in this respect, or that are engaged in any other activity involving medical devices and other devices of sanitary interest, and to establishments involved in any activity related thereto, within national territory.