Registration of medical device and medical equipment in Uzbekistan
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Content. |
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When registration through the representative — the power of attorney drafted in the established order. |
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General information about the medical device or medical equipment, about its manufacturer. |
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Copy of the Registration Certificate of the medical device or medical equipment in the country of origin, as well as in other countries (if available). |
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Normative document that includes the order and methods of testing a medical device or medical equipment, an international, interstate or national product standard. |
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Passport, operation manual of medical equipment, instruction for use of a medical device in Russian (for medical device - also in the state language). |
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Technical description of medical equipment. |
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Protocols of laboratory tests, technical tests, technical tests of medical measuring instruments, preclinical and clinical studies. |
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Compliance information of the conditions of production of medical devices and medical equipment with the requirements of international standards (if any). |
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Information about absence of infectious agents in products for «in vitro» diagnosis, prepared from biological materials. |
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Information on stability during storage of medical devices. |
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Illustrated promotional materials, brochures, catalogs, photo with size not less than 13 x 18 cm. |
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Colored graphic models of primary and secondary packaging (for medical devices). |
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Additional information about a quality, efficiency and safety of medical equipment, medical devices. |
Note: You can download this list:
See also:
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Pharmacopoeia CommitteeTasks of the Pharmacopoeia Committee:- examination of normative documents for medicines subject to registration and extension of the term of registration; - systematic revision of normative documents for medicines with a view to improving their quality and improving the methods of control; - examination and preparation for approval of additions and amendments of the... Read more |
Department of RegistrationTasks of the Registration Department:- after the adoption of the application for registration, conducts the initial (preliminary) examination of the application and attached registration documents and samples of medicines, medical devices and medical equipment; - conducts appropriate correspondence with the applicant on the... Read more |
Pharmacological CommitteeTasks of the Pharmacological Committee:- conducts examination of administrative, pharmacological, toxicological and clinical parts of registration documents of pharmacological and (or) medicinal products; - conducts examines and re-examines documents of pharmacological and (or) medicinal products with the involvement of independent experts; - decides on the use of the medicines without clinical trials in the... Read more |