Russia Medical Device Regulations

Agency

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 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 thePatient'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

Notes

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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