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Registration of medical products in Ukraine: procedure, documents, terms

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Sale and use of majority of medical products and equipment (hereinafter medical products) in Ukraine is possible only after their state registration. This applies to both medical products produced in Ukraine and those imported from abroad and are included to the list approved by the Order of the Ministry of Healthcare of Ukraine number 478 dated 02.07.2012. As of today the list includes medical instruments, apparatuses, devices, equipment, implants and materials designed to for the purpose of treatment and software required for their support as well as medical products for diagnostics, treatment, observation, conditions relief and a number of other products.

State registration of medical products is performed the State Administration of Ukraine on Medicinal Products, in particular by the Department of medical products state registration of Division on organization of the state quality and safety control for medical devices which is located in Kiev, Peremogy avenue, 120.

For the state registration two sets of documents must be submitted.

The application must contain the following information:

  • Names of medical products (in Ukrainian and English) and their numbers according to the catalogue;
  • Name of applicant (country of applicant’s registration, address, telephone, fax, e-mail);
  • Name of manufacturer (country of registration, address, telephone, fax, e-mail);
  • Medical products safety classification based on potential risks of their use (the legislation stipulates 4 levels of safety: I, IIa, IIb and III)

The following documents are added to this application:

  • manual (instruction) on medical product use;
  • certificate of origin of a medical product;
  • certificate of medical product compliance with the requirements of quality and safety;
  • copies of regulatory documents, information about standards, regulatory framework that serves as a base of product manufacturing;
  • documents on determination of medical product safety class based on the potential risks of use and also materials of preclinical and clinical examination/testing;
  • catalogue of medical products;
  • conclusion certificate of state metrology certification (for measuring instruments);
  • label or labeling sample for a medical product;
  • copy of state registration certificate or an extract from the Unified State Register;
  • document about payment of registration fee (payment order about state duty payment with bank’s notation). The amount of the fee when registering medical equipment is 850 UAH, when registering medical products – 340 UAH. The fee does not include cost of expertise.

On top of that if applicant is not a manufacturer the application must go along with a document that confirms his power for a state registration on manufacturer’s behalf (for example letter of attorney) which includes name of the person who will receive state registration certificate and its owner.

All the documents (originals or copies duly notarized by a body that issued the original) are submitted in triplicate with obligatory translation into Ukrainian (if they are in other languages).

When all the required documents are submitted the State Administration of Ukraine on Medicinal Products directs an applicant to an expertise establishment to perform expertise and testing of medical products. The particular expertise establishment is chosen by the applicant base of specialization of the establishment. But the choice is limited by the list of such establishments approved by the Order of the State Administration of Ukraine on Medicinal Products number 121 dated 22.02.2012. An applicant enters into medical products expertise and testing agreement with the chosen establishment. This agreement in particular stipulates term and cost of such expertise.

During expertise information that was provided by an applicant about safety, quality and effectiveness of a medical product is verified. Scope and content of an expertise depends on safety class of medical products in practice which was defined by an applicant. This class must be verified during the expertise. While performing an expertise an expertise establishment can demand provision of additional materials. At the same time term which is required for these materials preparation and submission is not included to the term of expertise. The maximal term of such materials provision is 30 days. Longer term is possible only if an applicant mails a letter with motivation which explains why longer term is required. If during this term the materials are not submitted then expertise and state registration is stopped and an applicant will have to submit all the documents one more time.

Based on the result of an expertise an expertise establishment prepares a conclusion which serves as a ground for testing of a medical product. The testing is appointed by the State Administration of Ukraine on Medicinal Products. Its term is not included to the term of expertise.

Based on testing results, conclusions of an expertise and recommendations of advisory body the State Administration of Ukraine on Medicinal Products makes a decision about registration of a medical product or about refusal of such registration. The decision about registration refusal can be made only when the conclusion of an expertise does not confirm safety, quality and effectiveness of a medical product. Ideally the decision about medical product registration or registration refusal is made within 90 days from the moment when the State Administration of Ukraine on Medicinal Products received the documents. But taking into consideration requirements for expertise and testing and delays related to them on the side of the State Administration of Ukraine on Medicinal Products and experts the term of registration may exceed the one stipulated in regulations. An applicant is supposed to be informed about made decision by the State Administration of Ukraine on Medicinal Products within 10 days.

If the decision is made about registration of a medical product an applicant receives Certificate of medical product state registration and the medical product itself is included in State register of medical equipment and medical products. Validity term of the Certificate is unlimited. For medical products made in Ukraine that have not passed qualification tests the validity term is 2 years. If such product includes a medical drug the validity term cannot exceed the term of registration certificate for such drug.

This material was prepared by our lawyers within Medical and Pharmaceutical law practice of our firm and it is also closely related to Registration of medical equipment or medical products.

 


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