Singapore legislation
Schedule 1
Schedule 1
Categories and descriptions of health products to which Act applies
FIRST SCHEDULESections 4, 29(1) and 73(1)Categories and descriptions of health products to which Act appliesFirst column Second column Third columnCategory Description Exceptions and limitations1.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 —
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.