Home Registration in CIS


Starting from July 1, 2015, Ukraine has introduced registration of medical products and devices according to new national regulations that are identical to the European directives for medical devices.

Documents checklist

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

Please contact our Regulatory Experts for more information