Russia`s New Medical Software Assessment Rules
Russia Medical Device Regulations

All medical devices are regulated by Roszdravnadzor (RZN) under Resolution 1416 as 2part of the Ministry of Health of the Russian federation
Medical Device Definition
Any medical appliances, apparatuses, devices, equipment, materials, and other products used for medical purposes either separately or in combination with each other and with other accessories required for the use of these products as intended, including customized software, and designed manufacturer (producer) for the prevention, diagnosis, treatment and aftercare of diseases, monitoring of the human body for medical research, medical tests, rehabilitation, replacement, modification of anatomy or physiological functions of the body, pregnancy prevention or termination, the functional purpose of which is not implemented by pharmacological, immunological, genetic or metabolic impact on the human body (hereinafter "medical devices")
Classification of Medical Device
International Classification Description Examples Risk Level
Class I Simple with history of safe use Simple surgical instruments, tongue depressor Low
Class II a relatively low risk to the human body Digestive catheters, infusion pumps, and powered wheelchairs Low - Moderate
Class II b Relatively high risk to the human body Dialyzers, and orthopaedic implants High - Moderate
Class III Devices that may endanger the Patient's life Coronary stents High
Premarket Approval Process
Class I Class II a Class II b Class III
Send device information and data to Russian test lab. These documents must be in Russian.
Submit import permit to RZN.
After RZN issues permit the device must be sent to a russian test lab.
Prepare Registration Dossier, including ISO, preclinical data, and test results. Documents must be translated into Russian.
Eligible for simplified process Russian supplemental clinical data required. Expertise Center may ask for more clinical results at this point.
Apply for Declaration of COnformity (DoC) certificate
  • Most documents must be translated into Russian
  • Device Registrations do not expire. DoC must be renewed every 1-3 years
  • Cost: Low

Source: WHO, RZN site

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