How to obtain a catalog of medical products for registration?
The use and sale of medical products and equipment in Ukraine is possible only if they are registered (declared).
According to paragraph 2 of the Resolution of the Cabinet of Ministers of Ukraine No. 1497 “On Approval of the Procedure for State Registration of Medical Equipment and Medical Products” of 09.11.2004, the concept of medical products includes devices, complexes, systems, equipment, apparatus, instruments, devices, implants, supplies, materials or other items, including invasive medical items; in vitro diagnostic medical devices; medical devices that do not achieve the main intended purpose in the human body or on it by means of pharmacological, immunobiological or metabolic means, but the functions of which such devices may contribute; medical devices used both separately and in combination with each other, including software necessary for their proper use, in order to ensure:
- prevention, diagnosis, treatment, observation or relief of the patient’s condition in the case of illness, trauma, injury or compensation;
- research, replacement or modification of the structure (anatomy) of organs, tissues or physiological processes;
- control of the fertilization process.
In this case, the most important document for registration is the catalog of medical products. In fact, the best way to get it is to seek legal advice, since it is not enough just to find a catalog – it is much more difficult to register a medical product based on this catalog. Therefore, please note that in any case, it is necessary to make changes to the catalog so that the State Service of Ukraine on Medicines and Drugs Control does not have any claims.
If you decide to register medical products, you need to prepare the following package of documents:
- the application for registration;
- the certificate of origin of medical products;
- the certificate of conformity of medical products for quality and safety for health;
- the instructions for the use of medical products;
- the copies of regulatory documents and the information about the standards and regulatory base on the basis of which medical products are created;
- the catalog of medical products;
- a document confirming the applicant’s registration;
- the receipt confirming payment of the registration fee.
Then you need to get the UKTVED (the Ukrainian Classification of Goods of Foreign Economic Activity) code for medical products, and then you will have the following steps:
- passing the preliminary examination of documents;
- testing the safety of a medical product, including preclinical, toxicological examination;
- safety studies: sterility studies, metrological and other measurements;
- studies of the effectiveness of a medical product (medical, clinical trials);
- the conclusion of the relevant state body and its registration in the journal;
- entering a medical product into the state register and issuing an original certificate and annexes.
Cost and terms
After preparing the necessary package of documents, you must contact the State Service of Ukraine on Medicines and Drugs Control, which, within up to 30 days, makes a decision on the registration of medical products, or refuses to register. Therefore, if you are not sure whether all the documents have been collected, or you need to register as quickly as possible, in this case it is better to contact a qualified lawyer who will resolve your issues as soon as possible.
Since 2012, the registration certificate has been issued indefinitely.
The registration fee for medical equipment is UAH 850, and for medical devices – UAH 340.
Also keep in mind that during the initial registration it is necessary to conduct the examination, the cost of which is UAH 10,000, and in the case of re-registration – UAH 3,000. Examination and trials should confirm the safety, quality and effectiveness of medical products. On the basis of the expert opinion, research results and recommendations of the advisory body, the State Service of Ukraine on Medicines and Drugs Control makes a decision on the registration of medical products or on the refusal to register them.