俄罗斯测试认证集团/海关联盟EAC认证中心
Центр сертификации EAC Таможенного союза ?ООО ТЕСТ СЕРТ
上海经合工业设备检测有限公司 俄语区域产品认证专家
· 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.