In this article, we provide answers to basic questions regarding the procedure for medical device registration according to the requirements of the EAEU: how is everything organized? How long does it take? How much does it cost?

1. What is the procedure?

The procedure takes place in 2 stages:

Registration (2 stages) takes from 100 to ≈ 250 wd.

1. What is the cost?

 

When registering in Russia as in a reference state:

• For issuing a registration certificate — 11,000 rubles.
• For carrying out an examination:

– risk class 1 – 72,000 rubles;

– risk class 2a – 104,000 rubles;

– risk class 2b – 136,000 rubles;

– risk class 3 – 184,000 rubles;

When registering in Russia as in a state of recognition:

• For approval of the expert report of the reference state:

– risk class 1 – 72,000 rubles;

– risk class 2a – 104,000 rubles;

– risk class 2b – 136,000 rubles;

– risk class 3 – 184,000 rubles;

References:

1. Decision of the Council of the Eurasian Economic Commission of February 12, 2016 N 46 “On the Rules for Registration and Examination of Safety, Quality and Efficiency of Medical Devices”
2. Federal Law No. 382-FZ dated November 29, 2021 “On Amendments to Part Two of the Tax Code of the Russian Federation”