What You Need?

To start with registration you need to prepare all necessary documents...

1. Documents confirming manufacture conditions (f.e. ISO, EC, company license etc.)
2. Power of attorney
3. Declaration of conformity
4. Documents describing technical processes and the product itself (technical file)
5. Documents confirming the product quality (test reports)
6. Instruction of use (operation manual)
7. Advertising materials
8. Product samples

- items 1, 2, 3 require apostille
- items 4, 5, 6 require apostille or notary stamp
- item 4 and 6 should correspond to the claims of Russian law of medical product registration