Medical devices are any instruments, apparatuses, appliances, equipment, materials or other devices whether used alone or in combination as well as with any accessories or custom software for its proper functioning, intended by the manufacturer to be used for prevention, diagnosis, treatment and medical rehabilitation, monitoring of the human body state, medical research, rehabilitation, replacement, changing of body’s anatomical structure or physiological(bio) functions, prevention or termination of pregnancy, and intended functional purpose of which is not implemented by pharmacological, immunological, genetic or metabolic effect on the human body
Medical devices are allowed for circulation on the territory of the Russian Federation after they have passed pre-market approval by Roszdravnadzor.
In accordance with the Regulation on the Federal service on Surveillance in healthcare, approved by the Resolution of the Government of the Russian Federation dated 30.06.2004 № 323 Roszdravnadzor is vested the following powers regarding medical devices:
- state control over circulation of medical devices;
- State registration of medical devices;
- monitoring of safety of medical devices;
- collecting and record keeping of notifications of start of circulation of medical devices practice (except for
carrying out clinical trials of medical devices, production, installation, check-out , application, operation of medical devices, as well as their maintenance and repair);
- maintenance of the State Registry of Medical Devices and Institutions (individual entrepreneurs) Manufacturing Medical Devices;
- licensing of manufacturing and maintenance (except for cases when maintenance of medical devices is carried out for legal entity or an individual entrepreneur’s own needs) of medical devices.