哈萨克斯坦共和国药品注册和医疗器械和医疗设备必须进行国家注册

The list of drugs, IMN and MT subject to state registration

欧亚经济委员会理事会 2017年9月4日第17号建议

对于在日期为2017年9月4日第17号清单上的标准，由欧亚联盟采取EAEU MED注册全部采用或部分采用，自愿确保医疗器械符合医疗器械安全性和有效性的一般要求，其标签和操作文档的要求。对于建议进行EAEU EAC MED医疗器械注册。

欧亚联盟EAC MED医疗器械注册强制性实施日期2022年1月1日

注意：总的来说，我的建议是至少等到2022年开始，届时注册规则将变得更加清晰。
1-现在开始俄罗斯本国国家医疗器械注册启动项目为时已晚。 从01/01/2022起，当前的俄罗斯医疗器械注册本国法规将停止提交，因此即使我们现在就开始已经没有足够的时间来准备文档和进行提交完成俄罗斯本国的医疗器械注册注册。只有等待2022年1月1日开始然后启动强制性欧亚联盟EAC医疗器械注册。

2-EAEU法规注册请联系我们，具体大约需要2021年1月1日启动。前提任何问题可以联系我们评估 

根据哈萨克斯坦共和国药品注册和医疗器械和医疗设备注册的法律要求，根据哈萨克斯坦共和国法典第71条“关于人民健康和医疗保健制度”。

什么哈萨克斯坦共和国药品注册和医疗器械和医疗设备注册机构？

哈萨克斯坦共和国药品注册和医疗器械和医疗设备注册、重新登记和修改，通过“电子政府”门户网站与哈萨克斯坦共和国统一卫生信息系统（SULO）的药物管理系统进行。

State registration and re-registration are subject to manufactured in the Republic of Kazakhstan, as well as imported into its territory drugs, medical devices and medical equipment, including:

药品注册和医疗器械和医疗设备哈萨克斯坦共和国注册产品范围：

1、drugs under the trade names with the indication of the dosage form, dosage, packaging;

2、original medicine;

3、bulk products of medicines, medical products;

4、new combinations of medicines previously registered in the Republic of Kazakhstan with indication of the dosage form, dosage, packaging;

5、medicinal products, previously registered in the Republic of Kazakhstan, but produced by other manufacturers, in other dosage forms, with new dosage, packaging and packaging, other auxiliary substances and the name;

6、medicinal substances not manufactured under good manufacturing practices;

7、drugs of one registration certificate holder produced in different countries at different production sites;

8、medical devices, including diagnostic reagents, contact lenses for vision correction, care products, medical equipment, taking into account their classification depending on the degree of potential risk of medical use;

9、medical devices and medical equipment, previously registered in the Republic of Kazakhstan, but manufactured by other manufacturers;

10、medical devices and medical equipment, previously registered in the Republic of Kazakhstan, but produced in other modifications, with new packaging, a different composition of component parts or a different name;

11、medical devices and medical equipment manufactured by one manufacturer at production sites located (located) in different countries;

12、consumables for medical devices and medical equipment that are medical products, except those specifically designed by the manufacturer for use with a medical product and medical equipment that can function only with this consumable material;

13、medical devices and medical equipment that are part of a specialized vehicle for the provision of medical care;

14、sets (kits) of medical products;

15、laboratory diagnostic devices;

16、medical devices and medical equipment for the prevention, diagnosis, treatment of diseases, assessment of the physiological state of the body, rehabilitation, medical procedures, medical research;

17、medical devices and medical equipment for replacing and modifying parts of tissues, human organs, restoring or compensating for impaired or lost physiological functions;

18、medical devices to control conception.

What document is issued upon completion of the registration procedure for drugs, medical devices and medical equipment? Form RU

1、The state body with a positive decision on registration, re-registration and making changes to the registration dossier of medical devices and medical equipment provides the applicant and expert organization in electronic form

2、registration certificate valid on the territory of the Republic of Kazakhstan;

3、approved instructions for the medical use of the medicinal product, medical devices in the state and Russian languages;

4、an agreed regulatory document on the quality and safety control of a medicinal product, a medical device with an assigned number;

5、approved mock-ups of packaging, labels, stickers on medicines, medical products.

Period of validity of the Registration Certificate

When state registration is established, the validity of the registration certificate is 5 years for medicines, up to 10 years for medicinal substance, medicinal plant raw materials, 5 years for medical products, 7 years for MT.

Upon expiration of the registration certificate of medicines, medical devices and medical equipment is subject to re-registration.

Is a registration certificate issued in the CU member states valid in Kazakhstan?

On the territory of the Republic of Kazakhstan, only the registration certificate issued by the state body of the Republic of Kazakhstan is valid.

Dates of examination

1、Examination of the medicinal product during state registration and introduction of changes requiring new registration shall be carried out within a period not exceeding two hundred and ten calendar days.

2、Duration of the examination of medical devices and medical equipment, depending on the safety class is 90-160 days.

Safety and quality assessment

The deadline for work to assess the safety and quality of medicines and medical products is 30 days.

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