海关联盟EAC认证中心

Центр сертификации Таможенного союза

021-36411223   Skype:gostchina
乌兹别克斯坦医疗器械认证,medical Uzbekistan regsitration,re-registration of if imported to Uzbekistan “Регистрация ИМН и МТ в Узбекистане”
来源: | 作者:pmta78c0f | 发布时间: 2018-11-08 | 320 次浏览 | 分享到:
乌兹别克斯坦医疗器械认证,medical  Uzbekistan regsitration,re-registration of if imported to Uzbekistan “Регистрация ИМН и МТ в Узбекистане”

List of documents required for registration

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.



We offer the services of registration:

·         Medical supplies and drug

·         Medical equipment

·         Food supplements and substances (API)

·         Veterinary products

·         Cosmetics and perfumery

 

 

Health care equipment and medical devices produced in Kazakhstan are eligible for state registration and re-registration of if imported to Uzbekistan taking into account their classification depending on degree of potential risk in medical applications, including the following:

·         medical products and medical equipment registered earlier in the Republic of Kazakhstan, but produced in other modifications, new packaging, a different composition of parts or different name;

·         medical products and medical equipment registered earlier in the Republic of Kazakhstan, but produced by other organizations-producers;

·         medical products and medical equipment produced by one manufacturer at the production sites located (hosted) in different countries;

·         medical devices and medical technology, registered in the producing country and (or) in the country of the holder of the production license;

·         medical products or medical appliances, having the medicine in the composition or being its integral part, are subject to state registration, re-registration as medical devices or medical equipment;

·         medical devices or medical technology, having a coverage of a medicine is subject to state registration, re-registration as a medical device or medical equipment;

·         medical products and medical equipment that include specialized vehicles to delivering medical aid;

·         medical products for conception control;

·         products of medical purpose and medical equipment for replacement and modification of parts of tissues, human organs; recovery or reparation of disrupted or lost physiological functions;

·         medical devices used for diagnostics outside the human body, except for the diagnostic reagents that are not related to medical immunobiological samples, as well as contact lenses for vision correction;

·         sets (sets) products of medical purpose;

·         laboratory diagnostic instruments;

·         medical devices and medical equipment intended for the prevention, diagnosis, treatment of diseases, assessment of the physiological state of the organism, rehabilitation, medical procedures, research of a medical character;

·         consumables for medical purpose products and medical equipment which are medical devices, except as specifically intended by the manufacturer for use with medical devices and medical equipment, capable to operate only with consumable;

The medicine registered in the country of manufacturer as medical products, with its characteristics and properties related to medicines, are subject to assessment as medicines.

A medicine included in the medical products and medical equipment or as a constituent part, is a specialized examination provided for medicines.

A medical product or medical technology, having a medicine coverage subject to state registration, re-registration as health care products or medical equipment.

State registration is not required  for medical products and medical equipment if intended for:

·         Exhibitions without the right of their further implementation; (exhibition samples of health care products and medical equipment);

·         Individual treatment of rare and (or) especially serious diseases;

·         Prevention and elimination of consequences of emergency situations;

·         Carrying out clinical researches and (or) tests;

·         Medical products manufactured in the medical equipment shops and health care products (individual orders);

·         Optical eye care manufactured in optical stores;

·         Diagnostic reagents that are not related to medical immunobiological preparations;

·         Science research laboratory diagnostic instruments;

·         Laboratory devices that are not used for disease diagnosis;

·         Components included in the medical products and medical equipment, and not used as a separate product or device.

Obligatory condition of state registration, re-registration is the examination of medical devices and medical equipment carried out by the state expert organization in the sphere of medicine circulation, products of medical purpose and medical equipment. Examination is conducted by state expert organization, not directly involved in the production and manufacture of medicines, health care products and medical equipment (hereinafter — the expert organization).

Expert organization defines the term of validity of registration certificate: five years for medical products and medical equipment up to seven years respectively.

Registration certificate of medical devices and medical equipment re subject to re-registration upon expiration of current registration.