Increase in state fees

To the attention of applicants submitting documents as part of the registration procedures for medical devices!

The Federal Service for Surveillance in Healthcare informs about an increase from 01.01.2022 in the size of the state duty for the commission of actions by the authorized federal executive body in the implementation of state registration of medical devices and registration of medical devices intended for circulation on the general market of medical devices within the Eurasian Economic Union. In accordance with Federal Law No. 382-FZ of November 29, 2021 “On Amendments to Part Two of the Tax Code of the Russian Federation”, the size of the state duty will be:

1. For the commission of actions related to the implementation of state registration of medical devices:

1) for the issuance of a registration certificate for a medical device – 11,000 rubles;

2) for the examination of the quality, efficiency and safety of a medical device during its state registration:

class 1 – 72,000 rubles;

class 2a – 104,000 rubles;

class 2b – 136,000 rubles;

class 3 – 184,000 rubles;

3) for making changes to the documents contained in the registration dossier of a medical device that do not require an examination of the quality, effectiveness and safety of a medical device – 2,500 rubles;

4) for conducting an examination of the quality, effectiveness and safety of a medical device when making changes to the documents contained in the registration dossier of a medical device:

class 1 – 32,000 rubles;

class 2a – 48,000 rubles;

class 2b – 64,000 rubles;

class 3 – 104,000 rubles;

5) for issuing a duplicate registration certificate for a medical device – 2,500 rubles.