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medical device "medical device" means- (a) any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of- (i) diagnosis, prevention, monitoring, treatment or alleviation of disease; (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; (iii) investigation, replacement or modification, or support of the anatomy or of a physiological process; (iv) support or sustaining life; (v) control of conception; (vi) disinfection of medical device; or (vii) providing information for medical or diagnostic purpose by means of in-vitro examination of specimens derived from the human body, which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means; and (b) any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, to be used on the human body, which the Minister may, after taking into consideration issues of public safety, public health or public risk, declare to be a medical device by order published in the Gazette;
ACT 737 - MEDICAL DEVICE ACT 2012
2. Interpretation |