Definition of Medical Device

Definition of Medical Device

“Medical Device” shall mean any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article:

(i) intended by the product owner to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
(a) diagnosis, prevention, monitoring, treatment or alleviation of 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; and
(g) providing information for medical or diagnostic purposes by means of Invitro examination of specimens derived from the human body;

(ii) 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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