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Web-based General Medical Device Classification Programme

 

Web-based General Medical Device Classification Programme

General Medical Device Classification Programme (Class I,II, III, IV general medical devices)
 
The following program is aiming to help traders in determining the classification of 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 device incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, and which is liable to act on the human body with action ancillary to that of the devices?
Q
Is this device manufactured from or incorporating animal or human cells / tissues / derivatives?
Q
Is this device intended specifically to be used for sterilising medical devices, or disinfecting as the end point of processing, but not intended to clean medical devices by means of physical action?
Q
Is this device used for contraception or the prevention of the transmission of sexually transmitted diseases?
Q
Is this an "Invasive Device"?
Q
Is this an "Active Device"?
Q
Is this device intended for therapeutic use by administering or exchanging energy?
Q
Q
Is this device intended to administer and/or remove medicinal products, body liquids or other substances to or from the body?
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