Registration of medical devices in Uzbekistan

Matters related to the 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 the state registration.

Possible ways of registration of medical devices

There are two 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 state registration procedure (through recognition) on 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.

Registration procedure

To conduct the state registration procedure, it is necessary to pass the following steps:

1. Submission of the full set of documents and samples of a medical device (if applicable)* to the State Centre of Expertise and Standardization of Medicinal Products, Medical Devices, and Medical Equipment under the Ministry of Health of the Republic of Uzbekistan (hereinafter – the Centre).

2. Payment of the official invoice for the expertise.

3. Expertise of safety, quality, and effectiveness of medical devices that includes:

preliminary expertise;
laboratory studies of the samples* (if required);
specialized expertise;
clinical studies** (if required);
inspection of the manufacturing site*** (if required).

* Exceptions for laboratory studies of the samples:

in vitro diagnostic medical devices (IVDs) prequalified by WHO and registered in collaboration with WHO;
medical devices declared for the simplified registration procedure (through recognition);
medical devices of Сlass I of the potential risk (excluding sterile, measuring and invasive devices).

** Clinical studies are not carried out in the following cases:

medical devices of Class I of the potential risk;
IVDs prequalified by WHO and registered in collaboration with WHO;
medical devices with clinical trials conducted in Uzbekistan;
medical devices declared for the simplified registration procedure (through recognition).

*** Inspection is not carried out in the following cases:

medical devices declared for the simplified registration procedure (through recognition);
IVDs prequalified by WHO and registered in collaboration with WHO;
if a valid ISO 13485 Certificate of the Republic of Uzbekistan is in place, but the production conditions of the medical device submitted for registration must be inspected during its manufacturing period for compliance with the national ISO 13485 standard.

4. Introducing data to the state register and issuing the Registration Certificate.

PAY ATTENTION

In accordance with Uzbek regulations, a foreign manufacturer is required to appoint an authorized representative with a registered office in Uzbekistan. Each medical device or equipment may be assigned to only one authorized representative. The authorized representative in Uzbekistan serves as the link between regulatory authorities, consumers and the manufacturer, ensuring post-marketing supervision. It acts based on the Power of Attorney issued by the manufacturer. If you do not have such a representative, we will be pleased to provide said service.

WHAT IS REQUIRED FOR REGISTRATION

To register a medical device or medical equipment, the following should be provided to the Centre:

1) Application form with the attached documents in electronic form;

Legalized Power of Attorney from the applicant to the representative;
Technical documentation for a medical device;
Legalized copy of ISO 13485 Certificate and/or other documents confirming compliance of manufacturing conditions with international standards;
Report on ISO 13485 inspection***;
Legalized copy of Declaration of Conformity concerning safety and efficiency of the medical device or other equivalent document;
Registration Certificates in the country of manufacture, as well as in other countries and/or other certificates issued by competent authorities of countries, where the medical device is registered or marketed;
Photos of the medical device, illustrated advertising materials, brochures, catalogues;
IP protection document (certificate, patent, annex), license agreement, or official opinion on trademarks/designs used in the medical device.

2) Samples of the medical device and standard samples (if applicable)* in an amount required for conducting tests (in the absence of the necessary equipment and conditions in the Republic of Uzbekistan, testing medical device samples shall be carried out in foreign laboratories with the participation of the Centre’s specialists)

DURATION OF REGISTRATION PROCESS

According to Uzbek legislation, the national state registration procedure on a medical device or medical equipment should be conducted within 60 to 120 working days, depending on the class of potential risk of a medical device or equipment, not including a time for preparation of responses to official requests (if any), clinical trials and inspection under ISO 13485 by the Uzbek Authority (if applicable)**/***. However, in accordance with usual practice, depending on the completeness of provided materials, scope of documentation, number of requests of the competent authority, and other factors, the state registration procedure on a medical device in Uzbekistan may take about 8-10 months, not including a time for preparation of responses to official requests (if any), clinical trials and inspection under ISO 13485 by the Uzbek Authority.

The time frame for examination of the registration materials under the simplified registration procedure (through recognition) is 15 working days after payment of the official fees. In accordance with usual practice, the simplified state registration procedure takes about 2-3 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 no later than 9 months before expiration of previous registration. Usual renewal procedure lasts within the same time frames as new registration procedure without laboratory studies of samples.

The Registration Certificate on recognition of the state registration of a medical device in Uzbekistan is valid for 5 years. Renewal procedure may be initiated before expiration of the previous registration.

For more detailed information, including on the costs associated with registration of medical devices or medical equipment in Uzbekistan, the list of documents required for submission, etc. please contact our specialists.