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哈萨克斯坦医疗器械注册 KAZAKHSTAN – REGULATION FOR MEDICAL DEVICES
    发布时间: 2018-09-20 09:04    

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。


哈萨克斯坦医疗器械注册

KAZAKHSTAN – REGULATION FOR MEDICAL DEVICES


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。

 

首次进入市场的主要方案


 

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。

哈萨克斯坦医疗器械注册

KAZAKHSTAN – REGULATION FOR MEDICAL DEVICES


National regulation system | Regulatory framework

Code of the Republic of Kazakhstan of September 18, 2009  On Public Health and  Public Health System.

Order of the Minister of Health of the Republic of Kazakhstan No 735 of Novemer 18, 2009 On approval of the Procedure of state registration, re-registration and amendments to registration dossier of medical products (drugs), medical devices and equipment.

Order of the Minister of Public Health of the Republic of Kazakhstan № 736 of November 18, 2009 On Approval of the Procedure of Expertise of Medicinal Products, Medical Devices, and Equipment.

Order of the Minister of Public Health of the Republic of Kazakhstan № 743 of November 19, 2009 about approval of assessment regulations of manufacturing conditions and quality assurance system during state registration of drug products, healthcare products and medical equipment.

 

| Main scheme for first entry into a market

 

Stage 1. You send request for quotation to SHANGHAI SEC.

Stage 2. Pre-clinical trials is chemical, physical, biological, microbiological, pharmacological, toxicological, and other experimental scientific trials or series of studies for examination of the product under study or physical effect of drugs, methods, preventive measures and methods, diseases diagnostics and treatment for the purpose of appraisal of the specific effect and(or) safety with regard to human health (by 735 order).

Stage 3. Clinical trials is a trial of medical devices and with a human subject carried out to determine and confirm the safety and efficiency of drugs, preventive methods and techniques, diseases diagnostics and treatment (by 735 order).

We can avoid real trials providing if manufacture protocols are good or on the ground of Russian protocols for example.

Stage 4. List of documents of registration dossier is formed based on safety class. Documents of registration dossier must include an authentic translation of all the documents into Russian. SHANGHAI SEC submits electronic dossier in NC by www.dari.kz.

Documents KZ registation

Stage 5. Before state registration, re-registration and amendments the expertise should be done. The expertise is performed by National Center for drugs and Medical Devices Expertise (NC).

The expertise consists of 3 stages:

§  primary expertise:

§  analytical expertise;

§  special expertise.

Each successive stage of expertise is carried out on basis of the positive conclusion of the previous one.

Stage 6. Factory inspection is provided mostly in two cases: first entry into a market and in case with medical devices which required special condition for installation and maintanance (MRI, X-Ray).

Stage 7. For the registered medical devices and equipment the governmental body issues marketing authorisation and hands the following documents within ten calendar days:

1) approved instruction for medical application of medical devices and equipment in the national and Russian languages;

2) approved packages and labels designs for medical devices.

Stage 8. Electronic registration certificate is valid for 5 years.

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