MIKHAILYUK SOROKOLAT & PARTNERS

Patent and Trademark Attorneys

Registration of medical devices in Uzbekistan

Issues associated with the state registration of medical devices are regulated by the Ministry of Health Protection of the Republic of Uzbekistan. In accordance with law of the Republic of Uzbekistan "On medicinal products and pharmaceutical activity" medical devices are allowed for use in Uzbekistan only after state registration.

In order to register a medical device it is necessary to provide the following to the State Centre of Expertise and Standardization of Medicinal Products, Medical Devices and Medical Equipment of the Ministry of Health of the Republic of Uzbekistan:

1) Application form with the attached documents:

  • legalized Power of Attorney from the applicant to the representative;
  • general information about a medical device including the information about its manufacturer;
  • legalized copy of registration certificate issued by the competent authority of country of manufacturer or justification of its absence;
  • legalized copies of registration certificates issued by the competent authorities of countries, where said medical device is registered, or justification of their absence;
  • methods of control of a medical device;
  • passport, manual for operation, instruction for use of a medical device;
  • technical description of a medical device;
  • protocols of laboratory tests, technical tests, preclinical and clinical studies;
  • legalized copies of documents confirming the compliance of the conditions of the manufacture of medical device with the requirements of international standards;
  • information about the absence of infectious agents in a medical device (required for in vitro diagnostics products prepared from biological materials);
  • stability data within the storage of a medical device;
  • illustrated advertising materials, brochures, catalogs, photo of size not less than 13 x 18 cm;
  • proposed mockups of primary and secondary packaging for the market of Uzbekistan;
  • additional information about quality, efficiency and safety of a medical device.

2) Samples of a medical device and standard samples if applicable in an amount required for conducting tests.

According to the Uzbek legislation the procedure of state registration of a medical device should be conducted within from 120 till 155 days depending on the type of a medical device without considering the time for preparation of responses to the remarks. However, in accordance with the usual practice depending upon the completion of the provided materials and scope of documentation, number of requests of the competent authority and other factors the procedure of state registration of a medical device in Uzbekistan may constitute about 6-8 months without considering the time for preparation of responses to the remarks.

The Certificate about the state registration of a medical device in Uzbekistan is valid for 5 years and after that it is necessary to renew it each time for the next 5 years. The procedure of the renewal of the registration must be initiated within 3 months before expiration of previous registration. The usual renewal procedure lasts within about 6-8 months without considering the time for preparation of responses to the remarks.

In order we could provide you with the information on costs associated with the registration of medical devices in Uzbekistan together with the detailed information and list of documents required from your side, the Power of Attorney form for execution, etc. please contact our specialists directly.

Tashkent

8 g, Bunyodkor Ave.

Shayhontohur District

Tashkent, 100027

Uzbekistan

Email: office@msp.uz