1. Application for medical product registration
2. Power of Attorney (manufacturer's official letterhead);
3. ISO 9001, ISO 14 001, CE (if available), Free Sale certificate, Declaration of Conformity, Registration Certificates — can be submitted in English.
4. User’s manual in Ukrainian language
5. Product label (draft in Ukrainian language)
6. Manufacturers business registration — can be submitted in English.
7. Sterilization Validation Report — can be submitted in English.
8. Risk Management — - can be submitted in English.
9. Clinical evaluation or documents/links to publications in medical journals, websites, etc. related to product usage on the local market — can be submitted in English.
10. Additional documents may be requested