The Russian Federation approved duties for state registration of MIs within the framework of the Unified Energy System. Changes to the Tax Code of the Russian Federation concerning the introduction of duties for state registration of medical devices at the level of the Eurasian Economic Union will come into effect on April 7.
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 ₽.