"medical device"
means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, including Group III and IV Hazardous Substances contemplated in the Hazardous Substances Act, 1973 (Act No. 15 of 1973)—
| (a) | intended by the manufacturer to be used, alone or in combination, for humans or animals, for one or more of the following: |
| (i) | diagnosis, prevention, monitoring, treatment or alleviation of disease; |
| (ii) | diagnosis, monitoring, treatment, alleviation of or compensation for an injury; |
| (iii) | investigation, replacement, modification or support of the anatomy or of a physiological process; |
| (iv) | supporting or sustaining life; |
| (v) | control of conception; |
| (vi) | disinfection of medical devices; or |
| (vii) | providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and |
| (b) | which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means; |
[Definition substituted by section 1(h) of Notice No. 19, GG 39585, dated 8 January 2016]