General information.

In accordance with the Ukrainian legislative system (Order #1497 of Cabinet of Ministers of Ukraine dated November 9, 2004) all medical devices and devices of medical purpose, imported to the custom territory of Ukraine, have to pass the registration procedure in accordance with the "Order of State registration (renewal) of medical devices and devices of medical purpose".

Our company is a professional, who takes care of the whole registration procedure. Our specialists will prepare registration dossier in accordance with local regulations, submit it to the authorities and provide the full control of the process until the registration certificate will be presented to you.

Approximate time period to register product – 2-3 months, this term can be seriously reduced (please contact us for details). Registration certificate is valid for 5 years from the date of State Registration. After expiry registration certificate can be renewed (re-registration).  

Description of procedure.

Step 1. After you decided to register the products with our help - we sign the CDA (Confidential Agreement).

Step 2. You send (by e-mail) the following list of documents to us to determine the price quotation:

• EAN code;
• short description of the product and it's composition;
• presentation (brochure);

During the next 24 hours we provide you with terms & price quotation (State and Bureau Cratia fees).

Step 3. If the price suits you - we sign the Contract and you transfer the dossier to us by any world courier (DHL, TNT, FedEX etc.). We issue the Invoice for the first instalment of Bureau Cratia fee (70%).

Step 4. We translate documentation, combine the dossier and request missing documents if needed. After that we submit dossier to the State Service of medicinal products and medical devices.

Step 5. Dossier is being directed to the Technical Expertise. During that step all documents are being expertise for safety, quality and efficiency. It usually takes from 1 to 4 weeks to complete this step.

Step 6. You send us the samples of the product by any world courier to complete the following three steps.

Step 7. Preclinical trials. We do our best to direct trials to the friendly base (centre) and speed up the procedure. Time period - from 2 to 5 weeks to complete.

Step 8. Expertise on sterility (if required). It usually takes from 2 to 4 weeks to complete that stage.

Step 9. Clinical trials (possible to evaluate simultaneously with Step 8). We do our best to direct trials to the friendly base (centre) and speed up the procedure. Time period - from 2 to 7 weeks to complete.

Step 10. After positive conclusion from Technical expertise, Sterility, Preclinical and Clinical trials product is being adopted on the session of the State Service (each last Thursday of the month).

Step 11. We send you the original registration certificate (market authorisation), second instalment (30%).