All medical devices are regulated by the Medical Device Branch of the Health Sciences Authority (HSA)
Medical Device Definition
A 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 or or compensation for an injury; (c) investigation, replacement, modification, or support of the anatomy or of physiological process; (d) supporting or sustaining life; (e) control of conception; (f) disinfection of medical devices; (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.
Classification of Medical Device
|Class A (Non-sterile)
|Class A (Sterile)
||Surgical retractors / tongue depressors
||Hypodermic Needles / suction equipment
||Lung ventilator / bone fixation plate
||Heart valves / implantable defibrillator
|Â Every manufacturer, importer, supplier, and registrant of a medical device must maintain a detailed record of every received complaint and submit it to the HSA for inspection.
Source: WHO, HSA