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 |
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