We created provide with high quality services in registration of pharmaceutical products in Uzbekistan. We are dedicated team for registration of medicine formulations and solving the problems during entire process

Medical devices and equipments in Uzbekistan

1) Content.申请表

2) When registration through the representative — power of attorney.授权书

3) General information about the medical device or medical equipment, and its manufacturer.制造商介绍

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). 企业法人营业执照，ISO13485工厂体系证书，中华人民共和国医疗器械企业生产许可证和中华人民共和国医疗器械注册证，中华人民共和国医疗器械产品出口销售证明书

5) Normative document that includes the order and methods of testing a medical device or medical equipment, an international, interstate or national product standard. 规范性文件：包括测试医疗设备或医疗设备的顺序和方法或国家产品标准。

6) Passport, operation manual of medical equipment, instruction for use of a medical device in Russian (for medical device - also in the state language). 产品技术护照，医疗设备操作手册，医疗器械使用说明（医疗器械 – 中文英文和俄文语言）。

7) Technical description of medical equipment. 医疗设备的技术描述和声明（包括详细注册）

8) Protocols of laboratory tests, technical tests, technical tests of medical measuring instruments,preclinical and clinical studies. 实验室试验报告：技术测试，功能性试验、毒理分析试验，生物相容性试验，临床试验报告

9) Compliance information of the conditions of production of medical devices and medical equipment with the requirements of international standards (if any).ISO13485， CE证书/CE一致性声明；其他FDA或其他国家的注册证证书和测试报告。

10) Information about absence of infectious agents in products for «in vitro» diagnosis, prepared from biological materials. 生物相容性报告，从生物材料制备的用于“体外”诊断的产品中不存在感染因子的信息。

11) Information on stability during storage of medical devices. 医疗器械储存期间的稳定性信息。

12) Illustrated promotional materials, brochures, catalogs, photo with size not less than 13 x 18 cm.宣传彩页，小册子，目录，尺寸不小于13 x 18厘米的每个型号照片。

13) Colored graphic models of primary and secondary packaging (for medical devices).包装的照片内包装，外包装。

14) Additional information about a quality, efficiency and safety of medical equipment, medical devices. 有关医疗设备的质量、效率和安全性的其他信息。

sending List of required documents for Registration in Uzbekistan.

Official cost depends on many factors, if possible send Product specification which will be registered, and i will revert with Prices.

Usually registration time is 6 months.



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