On the territory of Russian Federation the import and use of medical equipment is under control of the Federal Service for Supervision of Welfare (Roszdravnadzor).
The normative documentation establishes the Federal Law of the Russian Federation on November 21, 2011 Nr 323-FZ “On fundamental healthcare principles in the Russian Federation”. The process of Registration of medical products is governed by the DECREE No. 1416 from 27.12.12. The English translation of the document can be downloaded here.
On January 1, 2013 on the territory of the Russian Federation introduced a unified concept of “medical device”.
Medical products are any instrument, apparatus, appliances, equipment, materials and other products used for medical purposes, alone or in combination with each other, and together with the other accessories necessary for the application to these products for the medical purpose, including special software, designed and manufactured for the prevention, diagnostic, treatment and rehabilitation of diseases, monitoring the state of the human body, for medical research, rehabilitation, replacement, change the anatomical structure or physiological functions of human body, for preventing or abortion whose function is not implemented by pharmacological, immunological, genetic, or metabolic effects. Medical devices may be recognised as interchangeable if they are comparable in functionality, quality and technical characteristics and are able to replace each other.
Document confirming the registration of the medicinal product is the registration certificate of Roszdravnadzor.
Depending on the complexity and field of use of products and equipment, they are grouped into different risk classes:
CLASS 1 – LOW-RISK PRODUCTS
microscopes;
medical scales;
Hospital beds;
OR tables;
Dentists’ chairs;
stethoscopes;
Non-invasive electrodes;
Test spectacles, lenses and prisms;
Some products made of glass and polymers;
bedding;
Bandages and accessories;
Sphygmomanometer;
Instruments for the study of hypermetropia and stereoscopic vision;
some kinds of dental and surgical instruments for general purposes;
Consumables (paper tapeы for the recording process, disposable electrodes and some reagent kits);
Set of medical devices for hygiene, diagnostic and therapeutic purposes as well as for the care of the patient;
other products.
CLASS 2A – PRODUCTS WITH AVERAGE RISK
Audiometer;
Spirometer;
echosinuskopes;
Thermal imagers;
electromyographer;
hearing aids;
Laboratory equipment;
surgical suction pumps;
Disinfection chambers;
bactericidal lamps;
Glasses and contact lenses;
Gas analyzers and moisturizer;
fixed and flexible endoscopes;
dialyzers;
Devices for UHF, SHF, EHF, LF, magnetic therapy and laser therapy;
Apparatus for ventilation (stationary and mobile);
Containers for storage and transport of blood;
Oxygen, including the oxygen inhaler;
Lamps for the ultraviolet, infrared and polarized light;
dental materials (cement, plastics, composites);
other products.
CLASS 2B – PRODUCTS AT RISK
monitors;
rheographs;
plethysmographs;
oximeters;
electrocardiographs;
defibrillators;
cardiological analyzers;
EEG;
Apparatus for electrophoresis;
Products for the connection of bone;
X-ray films and cassettes;
Means for gamma-therapy;
Complex cardiac intensive care units;
Meters of heart rate;
Devices for intravenous and inhalation anesthesia;
Equipment for radioimmunoassay;
Electrical appliances and cryo-surgical laser;
Devices and systems for the topical diagnosis (except for the fixed and flexible endoscopes, etc.);
Dressing material with increased requirements, including fleece-free materials for burns and other injuries;
other products.
CLASS 3 – HIGH-RISK PRODUCTS
lithotripter;
prosthetic heart valves;
implants and implants;
prosthetic blood vessels;
intrauterine contraceptives;
devices for infusion and blood transfusion;
devices for hemodialysis, hemosorption, lymphosorption;
pacemakers, including implantable;
lung machine and other products, replacing vital organs;
other products.
We will be glad to support you in obtaining of the state registration certification and will provide you with the sufficient information about further requirements .
Execution time: up to 8 months after a complete package of documents is provided
Validity period: unlimited
