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網上一般醫療儀器分級程式

網上體外診斷醫療儀器分級程式

網上體外診斷醫療儀器分級程式 (級別A,B,C,D的體外診斷醫療儀器)
 
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
此產品是否作一般化驗用途但非製造、售賣或代表作指定體外診斷應用?
Q6.1
此體外診斷醫療儀器是否擬用以檢測腦脊髓液或血液是否含有傳播風險有限的傳染性病原體?
Q6.4
此體外診斷醫療儀器是否擬用以決定傳染性疾病狀況或免疫狀況,而得出錯誤結果有導致作出會令患者生命受到迫切威脅的治理決定的風險?
Q6.5.1
在使用此體外診斷醫療儀器後,並為治療作出決定前,是否需作進一步調查? 以及此體外診斷醫療儀器是否擬用以監察?
Q6.8
此體外診斷醫療儀器是否擬用以治理患有致命傳染病的患者?
Q6.9
此體外診斷醫療儀器是否擬用以普查胎兒的先天障礙?
Q7.2
該等體外診斷醫療儀器所得結果是否屬於初步結果,並須進行適當實驗室化驗等跟進措施?
Q9.2
此體外診斷醫療儀器是否樣本盛器?
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?
 

免責聲明

上述醫療儀器分級程式的結果僅供參考。由於醫療行政管理制度的涵蓋範圍會不時更新,因此醫療儀器的實際分級亦會有所更改。程式設計者及網頁管理員均不會對此分級程式結果的準確性負上或承擔任何法律責任。

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修訂日期 : 二零一四年五月十二日