Medical devices have become an increasingly important health care area in relation to their impact on health and health care. Medical devices cover over 8000 types of products, ranging from simple bandages, walking stick, contact lenses, wheelchair, through life maintaining implantable devices, equipment to screen and diagnose diseases and health conditions (example pregnancy test kit), to the most sophisticated diagnostic imaging and minimal invasive surgery equipment
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What is a Medical Device?
“Medical device” means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the specific purposes of
(a) diagnosis, prevention, monitoring, treatment or alleviation of any disease;
(b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
(c) investigation, replacement, modification, or support of the anatomy or of a physiological process;
(d) supporting or sustaining life;
(e) control of conception;
(f) disinfection of medical devices; or
(g) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body,
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
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What is not a Medical Device?
In general, medical device is intended to be used to achieve a medical function (including diagnostic, preventive or therapeutic). But it does not achieve its primary intended function by pharmacological, immunological or metabolic action.
Hence products that are not intended for use in preventing, diagnosing, curing or alleviating diseases, ailments, defects or injuries are not medical devices. Some examples of products that are not medical devices include, body toning equipment, magnetic accessories, etc.
Consumers should exercise judgement in evaluating the benefits and possible risks when using such products. When in doubt, consumers should always seek the advice of their trusted family doctors.
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Classification of Medical Devices
Medical devices may be classified into 4 risk classes.
Class | Risk Level | Device examples |
A | Low Risk | Surgical retractors / tongue depressors |
B | Low-moderate Risk | Hypodermic Needles / suction equipment |
C | Moderate-high Risk | Lung ventilator / bone fixation plate |
D | High Risk | Heart valves / implantable defibrillator |
Classification of a medical device will depend upon a series of factors, including:
- How long the device is intended to be in use
- Whether the device is invasive
- Whether the device is implantable
- Whether the device is active
- Whether the device contains a drug or biologic component
The classification rules are adopted from the guidance developed by the Global Harmonization Task Force.
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