1. Brief scheme of the registration procedure.

2. Particularities of the registration of medical device in Ukraine .

3. Terms and fees.

4. List of services of Cratia Ltd. performed for registration of medical device.

  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

1. Brief scheme of the registration 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:

During the next 2-3 days we provide you with terms and price quotation (State and Cratia Ltd. 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.).

Step 4. We translate documentation; combine the dossier and request missing documents if needed. If the conclusion regarding EAN code is missing – we submit the inquiry to the State Chamber of Commerce. After that we submit dossier to the State Authority of medicinal products and medical devices.

Step 5. Dossier is being directed to the technical expertise. Technical expertise is being evaluated at the specialized institution; expertise checks if all other dossier complies to current legislation, if all the documents are present. We accompany the dossier, answer on the questions or forward them to the manufacturer till the positive conclusion (protocol of the technical expertise).

Step 6. In the case if your dossier does not include information about preclinical or clinical studies, or sterility is applied – we manage the samples import procedure, what include submission of the inquiry and receipt of the permission for import, assistance in preparation of the custom documents, custom clearance and delivery of the samples to the sites of expertise.

Step 7. Preclinical studies (toxicological studies) are required to be performed after technical expertise. We chose the optimal site for evaluation of the preclinical studies, accompany the dossier, answer on the questions or forward them to the manufacturer till the positive conclusion (protocol of the preclinical studies).

Step 8. Expertise of sterility of samples of medical device (if sterility was applied). In that case import of the samples is required.

Step 9. Clinical studies is the most complicated and expensive part of the registration procedure. Clinical studies are being evaluated on the small group of volunteers at the chosen site (clinic or institute). We chose the optimal site for evaluation of the clinical studies, control the accuracy of the evaluation process, answer on the questions or forward them to the manufacturer till the positive conclusion (protocol of the preclinical studies).

Step 10. After positive conclusion from Technical expertise, Sterility, Preclinical and Clinical trials product is being adopted on the session of the State Authority of medicinal products and medical devices.

Step 11. During two weeks from the moment as product was adopted at the session – it will be included to the State registry of medicinal products and medical devices, control of the accuracy of the draft of registration certificate and issue of the original registration certificate. Original document will be sent by World Courier to the Customer.

2. Particularities of the registration of medical devices in Ukraine .

There are many different particularities and important details that should be taken in consideration. One of the most important point of the preparation of the product to registration in Ukraine – are correct determination of the EAN code, correct presentation of the Application and Annex to the Application.

Product's success depends on the professionalism and accuracy of the performed registration process. Following results can appear due to incorrect preparation of documentation and nonprofessional actions during registration of product:

Specialists of Cratia Ltd. are highly qualified professionals that have a big experience and all required knowledge for preparation and evaluation of the procedure with minimal risks and in shortest terms.

3. Prices and terms .

Price of Cratia Ltd . and size of the state fees are usually determined during 5 days from the receipt of the dossier: specialists of our company will estimate the amount of work that should be done and will perform the preliminary contact with expected sites of expertises to determine the costs component.

Total price of the registration can vary from 2500 to 8000 EURO, depending on the category of the product, EAN code, safety class and modifications list.

Term of registration depend on the documentation list and from product itself, and usually takes from 4 weeks (approximately 1 month) from the moment of submission of the Application.

4. List of services that will be performed by Cratia Ltd. for registration of the medical device:

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 renewal of registration of the medical device;
• structure of the registration dossier for registration of the medical device;
• contact us;