Structure of the registration dossier:

Following list of documents is required for registration of the medical devices in Ukraine [download in MS Word format] :

1. Application*

2. Annex to Application*

3. Power of Attorney*

4. Instruction, user's manual, catalogues, technical characteristics.

5. Certificate of registration of the medical device in manufacturer's country.

6. Certificate of origin or/and Free sales certificate.

7. Manufacturing license, other manufacturer's certificates.

8. CE certificate (Certificate of compliance to Directive 93/42/ ЕЕС ).

9. Declaration of conformity with mentioned safety class referred to Directive 93/42/ ЕЕС .

10. Certificates ISO 9001; ISO 13485. Other standard compliance certificates .

11. Protocols of the preclinical and clinical studies, other studies and scientific information.

12. Certificates of analysis/quality. Certificates for starting materials (frames).

13. Sterility certificate is applied, validation of sterility.

14. Labeling information.

* - document will be prepared by Cratia Ltd. (upon documentation of manufacturer) and sent to manufacturer for adoption. Points 3, 5, 6, 8, 10 should be notary certified copies.

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:

• detailed information about new registration of the medical device;

• detailed information about renewal of registration of the medical device;

• contact us;

Marketing license and state registration of medical devices, health instruments, healthcare equipment in Ukraine. Regulatory affairs on medical devices, approval of marketing permission on medical device. Ukraine, Kiev, Cratia Ltd. Marketing approval, regulatory affairs on medical devices, medical and healthcare goods in Ukraine. State registration of medical devices. Ukraine, Kiev, Cratia Ltd.

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