Home › Registration of medical devices in Ukraine Registration of medical devices in Ukraine
Importation of medical devices to Ukraine, their implementation and practical usage is possible only after their state registration.
The state registration of medical devices is a process of obtaining a registration certificate from the Ministry of Health after the necessary analysis and tests at the expert institutions.
Ecomed regularly carries out registration of medical devices in accordance with all requirements and regulations of the Ministry of Health of Ukraine (Resolution № 1497 dated by 09.11.2004, Order of the Cabinet of Ministers № 393, etc.).
Registration is performed on the basis of the application form and related documents submitted by the applicant who is responsible for production, safety, quality and effectiveness of medical devices to the Ministry of Health. The application form is included a package of documents with a list which is available here.
The Ministry of Health shall consider the materials in the manner prescribed by the Ministry of Health, for no longer than 90 days. After an initial review of the submitted documents, the Ministry of Health involves the expert institutions for the necessary examinations and tests of the medical devices and releases for the applicant the appropriate directions. Expert examination results are performed by the institution in a protocol (the report or the conclusion) that is sent or given to the applicant, and then to the Ministry of Health.
Basing on the opinion of expert bodies the Ministry of Health appoints testing of medical products. Time required for testing is not included to the time of examination. The scope and content of the examination (testing) depends on the degree of potential risk of using medical devices in medical practice (safety class), and the availability of protocols for clinical trials that have ever been performed before.
Basing on the results of the conclusions of examination (testing) and the recommendations of the advisory bodies MoH takes a decision about either the registration of medical devices or about the rejection of their registration (in case if the examination or testing conclusions are negative).
On the basis of the decision to register the medical devices, they are included into the State Register of Medical Equipment and Medical Devices, which is owned by MoH, and the applicant is given with a Certificate of Registration of medical devices.
The validity of the certificate comprises five years. After the certificate is expired, the import of the medical devices to the territory of Ukraine, their implementation and usage are only possible after the certificate renewal (re-registration).
Re-registration of medical products:
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