Issues associated with state registration of medical devices in Uzbekistan are regulated by the Ministry of Health of the Republic of Uzbekistan. In accordance with the law of the Republic of Uzbekistan "On medicinal products and pharmaceutical activity", medical devices are allowed for use in Uzbekistan only after state registration.
Possible ways of registration of medical devices
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 medical device/medical equipment samples;
2) Simplified procedure of 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.
What is required for registration
In order to register a medical device, it is necessary to provide the following to the State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment under the Ministry of Health of the Republic of Uzbekistan:
1) Application with the attached documents:
- legalized Power of Attorney from the applicant to the representative;
- general information about the medical device including the information about its manufacturer;
- copies of registration certificates and/or other certificates issued by competent authorities of countries, where the medical device is registered or marketed, or justification of their absence;
- medical device testing methods;
- passport, operation manual, instruction for use of the medical device;
- technical description of the medical device;
- protocols of laboratory tests, technical tests, preclinical and clinical studies;
- legalized copies of documents confirming compliance of the manufacturing conditions of the medical device with requirements of the international standards;
- information about absence of infectious agents in the medical device (required for in vitro diagnostics products prepared from biological materials);
- stability data within the storage period of the medical device (if applicable);
- illustrated advertising materials, brochures, catalogues, photos 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 the medical device.
2) Samples of the medical device and standard samples if applicable in an amount required for conducting tests.
Duration of registration process
According to the Uzbek legislation the National state registration procedure on a medical device should be conducted within 120 to 155 days depending on the type of a medical device or equipment without consideration of the time for preparation of responses to requests. However, in accordance with the usual practice, depending on completion of 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 consideration of the time for preparation of responses to requests.
The time frame for examination of the registration materials under the simplified procedure constitutes 15 days after concluding an agreement with the Uzbek Authority and payment of official fees. In accordance with the usual practice the procedure of simplified state registration lasts within about 2 months after submitting the documents.
Validity term and renewal
The Certificate about state registration of a medical device in Uzbekistan is valid for 5 years and after that it is necessary to renew it every 5 years. The procedure of renewal of registration must be initiated within 3 months before expiration of previous registration. Usual renewal procedure lasts within the same time frames as new registration procedure.
For more detailed information, including on the costs associated with registration of medical devices in Uzbekistan, list of documents required for submission, sample of the Power of Attorney for execution, etc. please contact our specialists.