The Russian Federation approved fees for services for state registration of MIs within the framework of the Unified Energy System

The document sets the following fees.

1. For issuing a registration certificate for a medical device — 7 000 ₽;

2. For carrying out of examination of quality, safety and efficiency of a medical product at its state registration:
— Class 1 — 45 000 ₽;
— Class 2a — 65,000 ₽;
— class 2b — 85 000 ₽;
— Class 3 — 115 000 ₽;

3. For the procedure of VIRD (introduction of changes to the documents contained in the registration dossier of a medical device), provided that the examination of the quality, efficiency and safety of MI is not required — 1 500 ₽;

4. For conducting the examination of the quality, efficiency and safety of MI in the procedure of VIRD:
— Class 1 — 20 000 ₽;
— Class 2a — 30,000 ₽;
— Class 2b — 40 000 ₽;
— Class 3 — 55 000 ₽.

5. For the coordination of the expert opinion on the assessment of the safety, efficiency and quality of the medical device during its registration within the framework of the EAEC:
— Class 1 — 45 000 ₽;
— Class 2a — 65,000 ₽;
— class 2b — 85 000 ₽;
— Class 3 — 115 000 ₽;

6. For the coordination of the expert opinion on the assessment of the safety, efficacy and quality of the medical device under the procedure of VIRD:
— Class 1 — 20 000 ₽;
— Class 2a — 30,000 ₽;
— Class 2b — 40 000 ₽;
— Class 3 — 55 000 ₽;

7. For issuing a duplicate registration certificate for MI — 1 500 ₽.