Registration of Medical Devices
1.2. Registration of medical devices is a state supervisory function carried out by the Federal Service for Supervision in Healthcare and Social Development with the aim of allowing medical devices to be produced, imported, sold, and used on the territory of the Russian Federation.
1.3. All medical devices intended for medical use within the territory of the Russian Federation and including instruments, apparatuses, tools, devices, kits, systems with software, equipment, accessories, bandaging and suturing materials, dental materials, reagent sets, control materials and reference standards, calibrators, consumables for analyzers, items made from polymeric, rubber and other materials, software that are used in medical purposes individually or in combination with each other and which are intended for:
- prevention, diagnosis (in vitro), treatment of diseases, rehabilitation, performance of medical procedures, medical research, replacement and modification of human tissues and organs, restoration or compensation of impaired or lost physiological functions, control over conception;
- exposure to the human body in such a way that their functional purpose is not achieved through chemical, pharmacological, immunological or metabolic interaction with the human body, although the mode of action may be supported by such means.
1.4. Registration of medical devices is carried out in the name of a legal entity or an individual entrepreneur specified in the registration application.
1.5. When carrying out state registration, the same requirements are imposed on Russian and foreign medical devices
Source: Order of the Ministry of Health and Social Development of Russia dated October 30, 2006 No. 735 "On Approval of the Administrative Regulation of the Federal Service for Supervision in the Field of Healthcare and Social Development on Implementation of the State Function of Registration of Medical Devices" (Registered by the Ministry of Justice of Russia November 30, 2006 No. 8542)
Морфология
Род
Понятие «регистрация изделий медицинского назначения» женского рода.
Склонение и число
| Падеж | Единственное число | Множественное число |
|---|---|---|
| Р | регистрации изделий медицинского назначения | регистраций изделий медицинского назначения |
| Д | регистрации изделий медицинского назначения | регистрациям изделий медицинского назначения |
| В | регистрацию изделий медицинского назначения | регистрации изделий медицинского назначения |
| Т | регистрацией изделий медицинского назначения | регистрациями изделий медицинского назначения |
| П | регистрации изделий медицинского назначения | регистрациях изделий медицинского назначения |