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 productsused for medical purposes either separately or in combination with each other and with otheraccessories 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 ClassificationDescriptionExamplesRisk Level
Class ISimple with history of safe useSimple surgical instruments, tongue depressorLow
Class II arelatively low risk to the human bodyDigestive catheters, infusion pumps, and powered wheelchairsLow - Moderate
Class II bRelatively high risk to the human bodyDialyzers, and orthopaedic implantsHigh - Moderate
Class IIIDevices that may endanger thePatient's lifeCoronary stentsHigh
Premarket Approval Process
Class IClass II aClass II bClass 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 processRussian 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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