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Registration of medical devices and medical equipment in Uzbekistan

Documents required for state registration of medicines in the Republic of Uzbekistan

№	Documents	Notes
1	Application. A document confirming the representative's authority (power of attorney) when submitting an application through a representative.	The power of attorney must be notarized, apostilled, or certified by the consulate.
2	Technical documentation for the medical device:
2.1	Information about the medical device: area of application, brief description, types, medical device and its composition, brief description of parts, if there is a medical device nomenclature (GMDN) and a unified product identifier (UDI).
2.2	Information on medicinal products contained in the medical device (composition, quantity of medicinal product, ratio of medicinal product to medical device, information on registration of medicinal product in the country of its production).	The documents listed in these paragraphs are not required for software and in vitro diagnostic devices.
2.3	Manufacturer Information: A list of divisions and subsidiaries, including their name, type of activity, legal address, form of ownership, composition, status, and management authority. A copy of the document granting the right to manufacture in the country of origin (if available).
2.4	Development and production information: technical drawing, production process diagram, key production stages, packaging, testing procedures, and release of finished products for free circulation. Production regulations for a domestic manufacturer of medical devices.	The documents listed in these points are not required for the software.
2.5	A list of standards or general specifications with which the medical device must comply (with information about it).
2.6	Regulatory document for a foreign medical device for in vitro diagnostics, regulatory document (draft) for a domestic medical device for in vitro diagnostics.	The documents listed in these points are not required for the software.
2.7	Risk Management and Analysis Report.
2.8	Information on the sterilization process, including process validation, microbial test results (bioburden level), bacterial endotoxins, with sterility testing methods specified (if applicable), and packaging validation details.td>	These documents are intended for sterile products. The documents listed in these paragraphs are not required for software and in vitro diagnostic devices.
2.9	Information on the compliance of a medical device with general requirements for safety, efficacy, labeling and operating documentation (general requirements).
2.10	Test reports (verification) and validation information conducted to demonstrate compliance of medical devices with general technical requirements.
2.11	Specialty and susceptibility testing reports for in vitro diagnostic devices.	The documents listed in these points are not required for the software.
2.12	Information on the absence of infectious agents in a medical device for in vitro diagnostics made from biological material.	The documents listed in these points are not required for the software.
2.13	Information on specialized software (if any): verification and validation results, software architecture and life cycle information, cybersecurity measures (integrity control, access control, data protection and tamper prevention), identification and marking, manufacturer test results and compliance tracking system.
2.14	Stability study report — with a translation into the state language of the test results and conclusions for products with an expiration date.	The documents listed in these points are not required for the software.
2.15	Adverse Event and Withdrawal Report (for newly developed and designed medical devices, this information is not provided): a list of adverse events associated with the use of the medical device, if several adverse events occur, the time period in which the reported events occurred, a brief description of each event and the total number of events of each type reported, and a coordination plan developed by the manufacturers to address the issues and resolve them in each of these events (if any). A plan for collecting and analyzing data on the safety and effectiveness of the medical device during the post-marketing phase.
2.16	Protocols of studies (tests) to assess their biological action, conducted to prove the compliance of the medical device with general biological requirements.	The documents listed in these paragraphs are not required for software and in vitro diagnostic devices.
2.17	Biosafety information.	The documents listed in these points are not required for the software.
2.18	A report confirming the clinical effectiveness and safety of a medical device.	For a class 1 medical device according to safety level, clinical efficacy is not required (with the exception of sterile, measuring and invasive medical devices).
2.19	Information on labeling and packaging (colored layouts measuring 13-18 cm with dimensions indicated, labeling text (in the state language and for foreign manufacturers in Russian or English).	The documents listed in these points are not required for the software.
2.20	User manual or instructions for the use of a medical device in the State language and in Russian or English.
3	A copy of the current certificate (according to ISO 13485) issued for the manufacturer's quality system.	Must be issued by a valid and accredited organization.
4	Declaration of conformity with safety and efficacy requirements.
5	Certificate of registration of a medical device in the country of manufacture or a document confirming registration (certificate of free sale, export certificate (with translation into the state language) or a copy of a document confirming registration in other countries.
6	Photograph of the medical product (showing the appearance of the product, components, consumables and materials) and catalogues	The documents listed in these points are not required for the software.
7	Production inspection report.
8	A security document (certificate, patent and appendix thereto) confirming the rights to intellectual property objects (trademarks and industrial designs) used in a medical device, or an agreement on their use or a conclusion of an authorized body in the field of intellectual property on the trade name and design of a medical device.

Notes:

The applicant may reasonably omit certain information from the documents.
Several modifications may be made to a single registration certificate for a medical device.
Applications for renewal of a registration certificate must be accompanied by reports from clinics in the Republic of Uzbekistan on the safety and efficacy of the medical device.

Registration of medical devices and medical equipment in Uzbekistan

Documents required for state registration of medicines in the Republic of Uzbekistan

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