Registration of medical device and medical equipment in Uzbekistan
List of documents submitted for state registration of medical devices and medical equipment in the Republic of Uzbekistan


1
Content.
2
When registration through the representative — the power of attorney drafted in the established order.
3
General information about the medical device or medical equipment, about its manufacturer.
4
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).
5
Normative document that includes the order and methods of testing a medical device or medical equipment, an international, interstate or national product standard.
6
Passport, operation manual of medical equipment, instruction for use of a medical device in Russian (for medical device - also in the state language).
7
Technical description of medical equipment.
8
Protocols of laboratory tests, technical tests, technical tests of medical measuring instruments, preclinical and clinical studies.
9
Compliance information of the conditions of production of medical devices and medical equipment with the requirements of international standards (if any).
10
Information about absence of infectious agents in products for «in vitro» diagnosis, prepared from biological materials.
11
Information on stability during storage of medical devices.
12
Illustrated promotional materials, brochures, catalogs, photo with size not less than 13 x 18 cm.
13
Colored graphic models of primary and secondary packaging (for medical devices).
14
Additional information about a quality, efficiency and safety of medical equipment, medical devices.

Note:
When extending the period of certification of a medical device, medical equipment, it is necessary to present in due course reviews of clinics of the Republic of Uzbekistan about effectiveness and safety of medical devices and medical equipment.



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See also:

Registration of medicines in Uzbekistan
Registration of dietary supplement and biologically active additives (BAA) in Uzbekistan
Registration of food additives and food supplements in Uzbekistan
Registration of cosmetics and perfumes, chemical substances, biological agents and materials, polymer and plastic materials in Uzbekistan
Registration of veterinary medicinal products, medicines, drugs and feed additives in Uzbekistan




Pharmacopoeia Committee

Tasks 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...


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Department of Registration

Tasks 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...;

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Pharmacological Committee

Tasks 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...;


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