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 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

 

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。

 国家监管体系|监管框架

 

2009918日哈萨克斯坦共和国公共卫生体系守则。

 

哈萨克斯坦共和国卫生部长关于批准国家注册程序,重新注册和修改医疗产品(药品),医疗器械和设备注册的命令。

 

20091118日哈萨克斯坦共和国公共卫生部长№736关于批准医药产品,医疗器械和设备专业知识程序的命令。

 

20091119日哈萨克斯坦共和国公共卫生部长№743关于在药品、保健品和医疗设备的国家注册期间批准制造条件和质量保证体系评估规定的命令。

 

阶段1.您向我们上海经合发送报价请求。

 

阶段2.临床前试验是化学,物理,生物,微生物学,药理学,毒理学和其他实验科学试验或一系列研究,用于检查研究中的产品或药物的物理作用,方法,预防措施和方法,疾病用于评估特定影响和(或)人类健康安全的诊断和治疗(按735的顺序)。

 

阶段3.临床试验是对医疗器械和人类受试者进行的试验,以确定和确认药物的安全性和效率,预防方法和技术,疾病诊断和治疗(按735顺序)。

 

如果制造测试报告非常好的或者例如是以俄罗斯测试报告/协议为基础,我们可以避免提供真实的试验。

 

阶段4.根据安全等级组成的准备注册档案文件清单。注册档案文件必须包括所有文件到俄语翻译。 我们通过www.dari.kzNC提交电子档案。

 

文件哈萨克斯坦KZ注册

 

阶段5.在国家注册,重新注册和修改之前,应该进行专业知识分析。专业知识由国家药物和医疗器械专家中心(NC)执行。

专业知识分析包括3个阶段:

主要专长:

分析专长;

专业知识

每个后续阶段的专业知识都是在前一个阶段的积极结论的基础上进行的。

 

阶段6.工厂检查主要分为两种情况:

首次进入市场;    

以及需要特殊安装和维护条件的医疗设备(MRIX射线)。

 

阶段7.对于注册的医疗设备和设备,政府机构在十个日历日内发布上市许可并交出以下文件:

 

1)批准的国家和俄语医疗器械和设备的医疗应用指导;

 

2)经批准的医疗器械包装和标签设计。

 

8阶段.电子注册证书有效期为5年。

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:

 

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

2original medicine;

3bulk products of medicines, medical products;

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

5medicinal 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;

6medicinal substances not manufactured under good manufacturing practices;

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

8medical 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;

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

10medical 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;

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

12consumables 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;

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

14sets (kits) of medical products;

15laboratory diagnostic devices;

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

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

18medical devices to control conception.  

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

1The 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

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

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

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

5approved 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

1Examination 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.

2Duration 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.