MEDICAL DEVICE REGISTRATION

Under supervision of the Federal Service for Supervision of Welfare – ROSZDRAVNADZOR, medical device registration (certificate) is issued. It is issued and recorded by the Federal Service of Welfare, in accordance with Russian Federal Law No.323-FZ 21.09.2011 “On fundamental healthcare principles in the Russian Federation”. Following is what is defined as medical device by the order, which require medical device registration.

Russian Federal Law Definitions

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 recognized as interchangeable if they are comparable in functionality, quality and technical characteristics and are able to replace each other

MEDICAL DEVICE REGISTRATION CLASS

Medical products are classified as per the degree of potential risk of application on medical purpose, and followings are major objects which fall under each different class.

CLASS 1 – LOW-RISK PRODUCTS

Microscopes
Medical scales
Hospital beds
OR tables
Dentists’ chairs
Test spectacles, lenses, prisms
Bandages and accessories
Dental and surgical instruments for general purposes
Etc.

CLASS 2A – PRODUCTS WITH AVERAGE RISK

Audiometer
Spirometer
Thermal imagers
Laboratory equipment
Surgical suction pumps
Disinfection chambers
Bactericidal lamps
Glasses and contact lenses
Devices for UHF, SHF, EHF, LF, magnetic therapy and laser therapy
Apparatus for ventilation
Containers for storage and transport of blood
Oxygen inhaler
Dental materials (cement, plastics, etc.)
Etc.

CLASS 3 – HIGH-RISK PRODUCTS

Lithotripter
Prosthetic heart valves
Implants
Prosthetic blood vessels
Intrauterine contraceptives
Devices for infusion and blood transfusion
Pacemakers
Lung machine and other vital organ replacers
Etc.

MEDICAL DEVICE REGISTRATION SPECIAL NOTES

Medical Registration and Certification is rather complicate, comparing to other certifications or registrations. It is directly connected to human health protection, which requires proper clinical test and efficiency evaluation reports to be submitted and reviewed by the committee.

RUSSIA

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