Hello, thank you for your enquiry. If the components of the medical device change the new registration certificate is required for such components or the existing certificate must be updated. As regards the packaging, is it hard to respond you since we need more information about what does exactly change.

Dear Sir, thank you for your enquiry. Yes, the CE marked products are admitted on the Ukrainian market, but you will have to obtain the local certificates as well. If the products are imported for personal use no certifications are required.

Hello! The fee for the issue of 1 Medical Device Registration Certificate from 01/01/2013 is 6.000 rubles (approx. 200 USD). The cost of the laboratory test may vary from device to device and its class of risk. The required tests are: biocompatibility and toxicity, EMC, general safety, clinical trials. Each test costs approximately 1.000 - 1.500 USD. Document translation and notary fees 1.500 - 2.000 USD. The overall cost of the registration may vary from 8.000 to 25.000 USD. 

Hello! You can find the answers to your questions in the Uniform Sanitary and Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Supervision (Control) approved by the Decision of the Customs Union N 299 of May 28, 2010.

Hi! Thank you for your enquiry. The Russian National hygienic conclusion certificate (i.e. expert report) has been partially abolished from 01/07/2010, and partially substituted by the Customs Union expert report and the Customs Union hygienic registration certificate.