Skip to content
 

网上一般医疗仪器分级程式

网上体外诊断医疗仪器分级程式

网上体外诊断医疗仪器分级程式 (级别A,B,C,D的体外诊断医疗仪器)
 
The following program is aiming to help traders in determining the classification of IVD medical device. Please select “Yes” or “No” answer after each question, the program will generate a suggested classification for the device after you answer all relevant questions. For visually impaired persons, this program is best operating with Browser FireFox 23 or above and screen readers such as CJAW 13 or NVDA. The user needs to press "Read to End" (insert key + arrow down) after selection of each "Yes" or "No" answer.
Q1
此产品是否作一般化验用途但非制造、售卖或代表作指定体外诊断应用?
Q6.1
此体外诊断医疗仪器是否拟用以检测脑脊髓液或血液是否含有传播风险有限的传染性病原体?
Q6.4
此体外诊断医疗仪器是否拟用以决定传染性疾病狀况或免疫狀况,而得出错误结果有导致作出会令患者生命受到迫切威胁的治理决定的风险?
Q6.5.1
在使用此体外诊断医疗仪器後,并为治療作出决定前,是否需作进一步调查? 以及此体外诊断医疗仪器是否拟用以监察?
Q6.8
此体外诊断医疗仪器是否拟用以治理患有致命传染病的患者?
Q6.9
此体外诊断医疗仪器是否拟用以普查胎儿的先天障碍?
Q7.2
该等体外诊断医疗仪器所得结果是否属於初步结果,并须进行适当实验室化验等跟进措施?
Q9.2
此体外诊断医疗仪器是否样本盛器?
Q
Is this device come into contact with injured skin?
Q
Is this device intended for channeling or storing body liquids or tissues, liquids or gases?
Q
Is this device intended for modifying the biological or chemical composition of blood, other body liquids, or other liquids intended for infusion into the body?
Q
Is this device invasive with respect to body orifices (other than those which are surgically invasive)?
Q
Is this device intended to be placed into the teeth?
Q
Is this device intended to undergo chemical change in the body (except if the devices are placed in the teeth)?
Q
Is this a breast implant?
Q
Is this device intended to administer medicinal products?
Is this device intended to administer medicinal products by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application?
Q
Is this device intended to be an active implantable medical device?
Q
Is this device intended to be used in direct contact with the central nervous system, the heart or the central circulatory system?
Is this device intended for use in direct contact with the central nervous system or to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body?
Q
Is this device intended to be life supporting or life sustaining?
Q
Is this device intended to supply energy in the form of ionizing radiation?
Q
Is this a reusable surgical instrument (other than those in Class IV)?
Q
Is this device intended to be connected to an active medical device ?
Q
Is this device supplied sterile and intended for single use?
 

免责声明

上述医疗仪器分级程式的结果仅供参考。由於医疗行政管理制度的涵盖范围会不时更新,因此医疗仪器的实际分级亦会有所更改。程式设计者及网页管理员均不会对此分级程式结果的准确性负上或承担任何法律责任。

上 一 页 返 回 页 首
修订日期 : 二零一四年五月十二日