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.
What is required for 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;
- copies of registration certificates and/or other certificates issued by the competent authorities of countries, where said medical device is registered or marketed, or justification of their absence;
- medical device testing methods;
- 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 (if applicable);
- illustrated advertising materials, brochures, catalogs, photo of size not less than 13x18 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.
Duration of registration process
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 or equipment 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.
Possible ways of registration of medical devices
At the same time, recent amendments to the regulations on registration of medical devices have been introduced in Uzbekistan. According to said amendments, in addition to the national state registration procedure described above, a simplified procedure has been established.
Thus, there are 2 options for state registration of medical devices and medical equipment in Uzbekistan:
1) National state registration procedure that stipulates examination of the registration dossier and conducting laboratory tests of the medical device/medical equipment samples and takes about 6-8 months without consideration of time for preparation of responses to the remarks;
2) Simplified procedure of the state registration of medical devices/medical equipment certified by one of the authorized bodies listed below:
- Food and Drug Administration, USA;
- Bodies authorized to issue a European Certificate of Conformity, EU;
- European Medicines Agency, EU;
- Pharmaceuticals and Medical Devices Agency, Japan;
- Ministry of Food and Drug Safety, Republic of Korea;
- Medicines and Healthcare products Regulatory Agency, United Kingdom.
The simplified procedure is available as of June 1, 2021. It stipulates examination of the registration dossier only and should be conducted within 15 days after concluding the Agreement with the Uzbek Authority and payment of official fees. In this case laboratory testing of samples is not required.
Validity term and renewal
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 registration must be initiated within 3 months before expiration of previous registration. The usual renewal procedure lasts for 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 registration of medical devices in Uzbekistan together with the detailed information and list of documents required from your side, as well as a Power of Attorney form for execution, etc. please contact our specialists directly.