Registration of medical devices in Russia

Registration of medical devices is a procedure, the purpose of which is to authorize the circulation of medical devices. After passing the registration procedure for medical devices, a document is issued – a Registration Certificate.

Medical devices include:

Tools;
Devices;
Appliances;
Equipment;
Materials;
Other products used for medical purposes alone or in combination with each other and / or other accessories;
Special software.

On the territory of the Russian Federation, only registered medical devices are allowed to circulate, in accordance with the procedure established by the Government of the Russian Federation, authorized by the federal executive body.

Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 defines the Rules for the state registration of medical devices.

Risk classification:

Class 1 – medical devices with a low degree of risk;
Class 2a – medical devices with an average degree of risk;
Class 2b – medical devices with a high degree of risk;
Class 3 – medical devices with a high degree of risk

* The state registration of medical devices is carried out within a period not exceeding 50 working days from the date of the decision to start the state registration of medical devices;

** The term for conducting clinical trials of a medical device of risk class 2a, 2b and 3 is not included in this 50-day period.

Depending on the risk class of the medical device, registration takes place in the following stages:

Stages of registration of devices of the 1st risk class

Stages of registration of devices of other risk classes

The amount of the state duty:

State duty for registration of a medical device – 11 000 rubles

State duty for the examination of the quality, efficiency and safety of medical devices:

Class 1 – 72 000 rubles;
Class 2a – 104 000 rubles;
Class 2b – 136 000 rubles;
Class 3 – 184 000 rubles.

Cost calculation:

List of information required to calculate the cost of registering a medical device:

Name of the medical device;
Purpose and scope;
Specifications;
The materials from which the medical device is made;
Analogues registered in the Russian Federation.

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