Here are the main items of expenditure:
1. State fees of Federal Service for Surveillance in Healthcare
State registration of medical product — 7,000 rubles.
Making changes to the registration certificate for the medical product — 1500 rubles.
Issuance of a duplicate registration certificate for a medical product — 1500 rubles.
Carry out an examination of the quality, efficiency and safety of medical products depending on the risk class.
- Class 1 — 72 000 rubles
- Class 2a — 104 000 rubles
- Class 2b — 136 000 rubles
- Class 3 — 184 000 rubles
2. The work of an engineer who develops documentation. This is a very important point, because any mistake delays you for a few months and once again forces you to pay duties.
3. Payment of laboratory researches. The amount depends on the product you 're testing.