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。
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.
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