Changes in Government fees for medical device approvals in Russia
Government fees for initial registration process as medical device consists of:
- Government fee for expertise review (depends on risk class, payment for expert center work reviews technical dossier);
- Government fee for registration process (for Roszdravnadzor work and actions with registration dossier, certificate):
| Medical device risk class | Before 2021 (RUB) | From 1st of Jan 2022 (RUB) |
| 1 (expertise) | 45 000 | 72 000 |
| 2а (expertise) | 65 000 | 104 000 |
| 2b (expertise) | 85 000 | 136 000 |
| 3 (expertise) | 115 000 | 184 000 |
| Government fee for registration process (all risk classes) | 7 000 | 11 000 |
Government fee for amendments in registration dossier or registration certificate has two parts as well:
- Government fee for changes in registration dossier – as a payment for expert center work (depends on potential risk class, required if there are changes in technical dossier, not only in registration certificate as a document);
- Government fee for amendment process (payment for Roszdravnadzor work) :
| Medical device risk class | Before 2021 (RUB) | From 1st of Jan 2022 (RUB) |
| 1 (expertise) | 20 000 | 32 000 |
| 2а (expertise) | 30 000 | 48 000 |
| 2b (expertise) | 40 000 | 64 000 |
| 3 (expertise) | 55 000 | 104 000 |
| Government fee for registration process (all risk classes) | 1 500 | 2 500 |