What is Medical Devices?
1.Any instrument, apparatus, machine, implant, in vitro reagent that used inside or outside laboratory, material, software or related article intended by the manufacturer or product owner to be used in humans or animals, alone or combination for the specific purpose(s) of 1.
(a) diagnosis, prevention, monitoring, treatment or alleviation of human or animal diseases
(b) diagnosis, monitoring, treatment of or compensation for an injury in human or animal
(c) investigation, replacement, modification, or support of the anatomy or of a physiological process in human or animal
(d) supporting or sustaining life of human or animal
(e) control of conception or aid in the reproduction of human or animal
(f) aiding or compensation for the disability of human or animal
(g) providing information for medical diagnostic purposes by means of
in vitro examination of specimens derived from human or animal
(h) disinfection of medical devices
Achievement of the purposes according to (1) in or on human or animal bodies must not intend by pharmacological, immunological or metabolic means.
2. Accessories pursuant to (1)
“Accessory” means the article, apparatus or product that is intended specially by its manufacturer or product owner to be used together with a particular medical device to enable or assist that device to be used in accordance with its intended purpose
3. Instruments, apparatus, machines, products or other articles declared by the Minister as medical device