List of the documents to the application for registration of medical products
List of documents and materials for state registration (re-registration)
of medical equipment and medical devices
1. A numbered list of the documents and materials submitted for registration2. An application in the prescribed form
3. The electronic version of the application and the list of medical products submitted for the state registration, indicating the catalogue numbers (in Ukrainian and English)
4. A document evidencing the applicant's authority for state registration on behalf of the manufacturer, indicating the name of the recipient of the state registration certificate and its owner
5. Guidelines (manual) on medical products use
6. A certificate of origin of medical products
7. A certificate of compliance of medical products with the requirements for quality and safety for human health
8. Copies of legal documents, information on standards and regulatory basis according to which the medical products are manufactured
9. Materials for the safety class definition of medical products depending on the degree of potential application risk
10. Materials of pre-clinical studies and/or trials of a medical product
11. Materials of clinical studies and/or trials of a medical product
12. A catalogue of medical products
13. An opinion of the state metrological certification - for measuring instruments
14. A label or a labelling sample of medical products
15. A copy of the applicant’s registration document
16. A document evidencing payment of registration fee
All documents (originals or copies certified by a notary or the authority that issued the original document) are submitted in triplicate accompanied with a Ukrainian translation.
List of documents and materials for state registration (re-registration)
of medical equipment and medical devices
A numbered list of the documents and materials submitted for registration
An application in the prescribed form
The electronic version of the application and the list of medical products submitted for the state registration, indicating the catalogue numbers (in Ukrainian and English)
A document evidencing the applicant's authority for state registration on behalf of the manufacturer, indicating the name of the recipient of the state registration certificate and its owner
Guidelines (manual) on medical products use
A certificate of origin of medical products
A certificate of compliance of medical products with the requirements for quality and safety for human health
Copies of legal documents, information on standards and regulatory basis according to which the medical products are manufactured
Materials for the safety class definition of medical products depending on the degree of potential application risk
Materials of pre-clinical studies and/or trials of a medical product
Materials of clinical studies and/or trials of a medical product
A catalogue of medical products
An opinion of the state metrological certification - for measuring instruments
A label or a labelling sample of medical products
A copy of the applicant’s registration document
A document evidencing payment of registration fee
All documents (originals or copies certified by a notary or the authority that issued the original document) are submitted in triplicate accompanied with a Ukrainian translation.