The main legislative act regulating the procedure for state registration of medical devices is Decree of March 23, 2018 No. 213 “Regulation on the procedure for state registration of medicines, medical devices and medical equipment and the issuance of a marketing authorization.”
The competent authority responsible for the expert evaluation of documentation, making a decision on registration and issue of a Marketing Authorization for medical devices is the State Center for Expertise and Standardization of Medicines, Medical Products and Medical Equipment of the Agency for the Development of the Pharmaceutical Industry of the Ministry of Health. A
The Applicant (Holder) of a Marketing Authorization can be a legal entity, both resident and non-resident of Uzbekistan. The name and mailing address of such a legal entity obtaining the marketing authorization is indicated on the document.
A non-resident Applicant is not required to establish a company or representative office in Uzbekistan, and not required to designate an Authorized representative. However, the name and address of the organization accepting claims (proposals) on the quality of medical devices in the territory of the Republic of Uzbekistan must be indicated on the instructions for use (user’s manual).
The documentation for registration consists of the administrative part, technical description and test results, color advertising materials and graphic layouts. The Application for registration shall indicate the trade name of the medical device, model and modifications, and components.
Availability of the registration of the medical device registration in other CIS countries, such as Kazakhstan, Belarus or Ukraine, has a significant positive effect.
It is allowed to submit the registration dossier in English with the translation of part of the documentation into Russian. Instructions for use (user’s manual) in the Uzbek and Russian languages must be submitted.
The medical device registration procedure in Uzbekistan can be summarized in the following steps:
- Submission of the Application for registration, registration dossier, and, if necessary, samples of a medical device;
- Initial (preliminary) expert evaluation;
- Signing of an Agreement between the Applicant and the State Center for Expertise and Standardization;
- Receipt and payment of invoices for expert evaluation;
- After confirmation of payment, registration materials and samples are sent for specialized expert evaluation to the structural units of the State Unitary Enterprise “State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment”:
- Committee on New Medical Equipment;
- Inspection (if verification of manufacturing conditions is required).
- In the course of expert evaluations and studies, questions and/or comments may arise that the Applicant must answer within the established time frame.
- On the basis of expert evaluations and studies, positive opinions are drawn up.
- Opinions and/or protocols are issued;
- A decision on the registration of the medicinal product is made at a meeting of the Expert Council;
- The decision of the Council and the materials are transferred to the Main Directorate for Quality Control of Medicines and Medical Equipment of the Ministry of Health for the publication of the Order on Registration.
- A Мarketing Аuthorization is issued to the Applicant after signing the Order.
Instructions for use (package leaflet) and color packaging layouts in Uzbek and Russian languages are submitted, assessed and approved within the registration process.
Deficiency letters of the competent authority should be answered in a period not exceeding 45 working days.
The total registration period of a medicinal product should not exceed 155 working days from the date of submission of the Application. The time required for the Applicant to answer on the deficiencies is not included in the total registration period.
The validity of the Marketing Authorization (state registration certificate) is 5 years.
Changes and variations
During the validity of the Marketing Authorization, the Applicant may submit an Application for changes. The Application must be amended with relevant documents, and in some cases related to changes in quality of the product, samples and standards can be required.
The Application and the registration materials are examined in a period of not more than 90 working days. The time required for the Applicant to answer on the deficiencies is not included in the total assessment period.
Renewal of registration
Renewal of registration is required to extend the validity of the certificate for the next 5 years, as well as for the change of the Marketing Authorization Holder (MAH transfer).
An Application in the case of renewal of the validity of the marketing authorization should be submitted not later than in three months before the expiry. The requirements for the content of the registration dossier, the timelines and steps of the expert evaluation are identical to the new registration procedure. The duration of the procedure is 120 days, which does not include the time to respond to the deficiencies.
As a result of the renewal procedure, a Marketing Authorization (registration certificate) is issued for the next 5 years.
Cratia provides professional services of state registration of medical devices in Uzbekistan. We have an excellent knowledge of national legislation, necessary experience and resources.