Renewal and changes to the registration certificate of medical device:

Certificate of state registration of medical device is valid for 5 years. Not later than 90 days from the date of the expiry of registration certificate, the Application for renewal of registration should be submitted to prolong validity of the certificate for the next 5 years.

Procedure of the renewal of registration can also be initiated to implement changes (variations) to the registration materials (for example – change of the name of the product, additional manufacturer, extending the list of modifications and so on).

To perform renewal of registration for prolongation of the validity of the registration certificate, and in the cases of some circumstances during implementing of the changes – there is no need of clinical and preclinical studies, procedure is simplified. Sum of the fees and term of registration is reduced accordingly.

Total price of the re-registration of the medical device, in the case if changes do not require preclinical and/or clinical studies – can vary from 1500 to 3500 EURO, depending on the category of the product, EAN code, safety class, list of modifications and other attributes.

In the case if registration materials were seriously modified and will be decided that preclinical and clinical studies are required – prices and terms of the procedure will be similar to the new registration procedure.

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

• consulting regarding presentation of the information;

• translation of the updated documents (required parts), including notary translation of the documents;

• preparation of the Application and Annex (list of modifications);

• combing and mounting the dossier in accordance with requirements of the legislation;

• submission of the application and dossier to the State Agency of medicinal products and medical devices;

• accompanying the dossier during expertise and studies, defending interests of the Customer;

• expenses for World Courier (DHL);

• all other expenses; service fee defrays all charges required for renewal of registration including State fees;

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:

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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