General Medical Device Classification Program

General Medical Device Classification Program

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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?

Choice
Q

Is this device manufactured from or incorporating animal or human cells / tissues / derivatives?

Choice
Q.1

Does this device incorporate human blood, blood products, plasma or blood cells of human origin, except for stable derivatives device?

Choice
Q.2

Is this device a transplant or tissues or cells of human origin or product incorporating or derived from tissues or cells of human origin?

Choice
Q.3

Is this device a transplant or tissues or cells of animal origin, unless it is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissues?

Choice
Q.4

Does this device incorporate viable animal or human cells / tissues / derivatives?

Choice
Q.5

Does this device come in contact with intact skin ONLY?

Choice
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?

Choice
Q.1

Is this device intended for disinfecting, cleaning, rinsing or hydrating contact lenses?

Choice
Q.2

Is this device intended for disinfecting medical devices prior to end point sterilization or higher level disinfection?

Choice
Q

Is this device used for contraception or the prevention of the transmission of sexually transmitted diseases?

Choice
Q.1

Is this device an implantable or long-term invasive device?

Choice
Q

Is this an "Invasive Device"?

Choice
Q.1

Is this device intended for continuous use for less than 60 minutes?

Choice( Transient Use )
Q.2

Is this device intended for continuous use for more than 30 days?

Q

Is this an "Active Device"?

Choice
Q

Is this device intended for therapeutic use by administering or exchanging energy?

Choice
Q.1

Is this device intended to control or monitor the performance of Class III active therapeutic devices or intended directly to influence the performance of such devices?

Choice
Q.2

Can this device administer or exchange energy to or from the human body in a potentially hazardous way, including ionizing radiation, taking account of the nature, the density and site of application of the energy?

Choice
Q

Is this device intended for diagnosis?

Choice
Q.1

Is this device intended to emit ionizing radiation and intended for diagnostic and/or interventional radiology, including devices which control or monitor such devices, or those which directly influence their performance?

Choice
Q.2

Is this device specifically intended for the functions described below?

a) Monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of central nervous system , orb) Diagnosing in clinical situations where the patient is in immediate danger.
Choice
Q.3

Is this device used solely to illuminate the patient's body, with light in the visible or near infra-red spectrum?

Choice
Q

Is this device intended to administer and/or remove medicinal products, body liquids or other substances to or from the body?

Choice
Q.1

Does this device require any procedure that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode and route of administration?

Choice
Q

Is this device come into contact with injured skin?

Choice
Q.1

Is this device intended to be used principally with wounds which have breached the dermis?

Choice
Q.2

Is this device intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent?

Choice
Q

Is this device intended for channeling or storing body liquids or tissues, liquids or gases?

Choice
Q.1

Is this a blood bag?

Choice
Q.2

Can this device be connected to an active device in Class II or a higher class?

Choice
Q.3

Is this device intended for channeling or storing body liquids or tissues, liquids, or gases for the purpose of eventual infusion, administration or introduction into the body?

Choice
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?

Choice
Q.1

Does the treatment of this device consist of filtration, centrifuging or exchanges of gas or of heat?

Choice
Q

Is this device invasive with respect to body orifices (other than those which are surgically invasive)?

Choice
Q.1

Is this device intended to be connected to an active medical device in Class II or a higher class?

Choice
Q.2
Is this device intended for use in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane?
Choice
Q

Is this device intended to be placed into the teeth?

Choice
Q

Is this device intended to undergo chemical change in the body (except if the devices are placed in the teeth)?

Choice
Q

Is this device intended to have a biological effect or be wholly or mainly absorbed?

Choice
Q

Is this a breast implant?

Choice
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?
Choice
Q

Is this device intended to be an active implantable medical device?

Choice
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?
Choice
Q

Is this device intended to be life supporting or life sustaining?

Choice
Q

Is this device intended to supply energy in the form of ionizing radiation?

Choice
Q

Is this a reusable surgical instrument (other than those in Class IV)?

Choice
Q

Is this device intended to be connected to an active medical device ?

Choice
Q

Is this device supplied sterile and intended for single use?

Choice
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Disclaimer

The above classification program 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 program.