State Registration of medical devices and equipment

We render a vast spectrum of services in the field of consulting, registration and certification of Russian and foreign medical devices and equipment.

In accordance with the law of the Russian Federation all medical devices, meant for medical application on the territory of RF are subject to the procedure of State registration. These devices include all instruments, tools, facilities, sets, complexes, systems with software tools, equipment, fixtures, dressings and suture materials, dental products, RGT kits, control materials reference standards, calibration instruments, analyzer expendable materials, devices made of polymeric, rubber and other materials, software, which are used for medical purposes whether separately or in combination with each other and which are meant for:

- prophylaxis, diagnostics (in vitro), disease treatment, post-hospital rehabilitation, medical procedures, medical trials, surrogation and modification of tissue parts and/or human organs, functional recovery or compensation in case of  dyspraxia, control over impregnation;

- human exposure in such a manner, that their functional purposes are not realized  by means of chemical, pharmacological, immunological or metabolic interaction with the human body, though, their mode of action can be  maintained by such means.

List of the documents, required for  registration of medical devices