Introduction, general information:

Obligatory requirement for import and sale of the medical devices in Ukraine is a state authorization (registration). Procedure of the registration is mainly described in Decree of Cabinet of Ministers of Ukraine №1497 dated 09.11.2004 “Order of the state registration (renewal of registration) of medical devices and devices of medical purpose”.

State agency responsible for registration of the medical device is State Authority of medicinal products and medical devices of Ministry of Health of Ukraine (hereinafter – State Authority, website is www . dslz . gov . ua ).

Registration certificate for medical device is valid for 5 years. Not later than 90 days before expiry of the certificate – Application for renewal of registration for the next 5 years can be submitted.

Medical devices that are listed in Decree of Cabinet of Ministers №1949 dated 17.12.2003 are free from VAT tax (20%).

New registration of the medical devices requires the following steps to be done:

1. Receipt of the decision of the Chamber of commerce of Ukraine regarding EAN code for the device.

2. Submission of the Application to the State Authority.

3. Preliminary expertise of the dossier (presence of all documents).

4. Technical expertise of the registration materials.

5. Preclinical ( toxicological ) studies .

6. Sterility studies (if sterility is applied).

7. Clinical studies.

8. Adoption of the device for state registration on the session of the State Authority.

9. Including of the medical device to the State registry of medical devices, issue of the original registration certificate.

Session of the Stare Authority that adopts medical devices for state registration is held every two weeks.

Cratia Ltd., in accordance with your need, can execute either separate parts of the registration procedure (for example – medical translations, preparation of the dossier for submission) as well as the entire service of state registration of the medical device in Ukraine .

We usually provide initial consulting for free – please do not hesitate to contact us.

If you are interested in services of our company in the field of state registration of the medical device – you can find the following additional information at our website: