Medical device

Medical device refers to any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used alone, or in combination, for human beings, for one (1) or more of the specific purposes of: diagnosis, prevention, monitoring, treatment, or alleviation of disease; diagnosis, monitoring, treatment, or alleviation of or compensation for an injury; investigation, replacement, modification or support of the anatomy of a physiological process; supporting or sustaining life; preventing infection; control of conception; disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body. This device 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, as defined under Republic Act No. 9711. (Sec. 5(y), R.A. No. 10918)