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Web-based General Medical Device Classification Programme

 

Web-based In Vitro Diagnostic Medical Device Classification Program

In Vitro Diagnostic Medical Device Classification Programme (Class A, B, C, D in vitro diagnostic medical devices)
 
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
Is this a product for general laboratory use not manufactured, sold or represented for use in specified in vitro diagnostic applications?
Q6.1
Is this IVD medical device intended for use in detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation?
Q6.4
Is this IVD medical device intended for use in determining infective disease status or immune status, and where there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient?
Q6.5.1
Is therapy decision when using this IVD medical device made only after further investigation or is this IVD medical device used for monitoring?
Q6.8
Is this IVD medical device intended for use in the management of patients suffering from a life-threatening infectious disease?
Q6.9
Is this IVD medical device intended for use in screening for congenital disorders in the fetus?
Q7.2
Is the result of this IVD medical device preliminary and requires follow-up with the appropriate laboratory test?
Q9.2
Is this IVD a specimen receptacle?
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?
 

Disclaimer

The above classification programme are rough indications for references only. The actual classification of the medical devices is subject to the provision of the Medical Device Administrative Control Systerm (MDACS) which may be updated from time to time. The programme designer and the manager of this page take no responsibility for the accuracy of the above classification programme.

 
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Last Revision Date : 12 May 2014