All medical devices are regulated by The PhilippinesTM Food and Drug Administration (FDA), under the Department of Health.
Medical Device Definition
Refers to any instrument, apparatus, implement, machine, implant, in vitro reagent or calibrator, software, material or other similar or related article: a. intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: - diagnosis, prevention, monitoring, treatment, alleviation of diseases, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury, - investigation, replacement or modification or support of the anatomy or of a physiological process, - supporting or sustaining life, - control of conception, - disinfection of medical devices, - providing information for medical or diagnostic purposes by means of in vitro examination of specimen derived from the human body; and b. 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 their intended function by such means.
Classification of Medical Device
|International Classification||Examples||Risk Level|
|A||Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale||Low|
|B||Pregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask||Low - Moderate|
|C||Blood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lens||High - Moderate|
|D||HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker||High|
|Postmarket Surveillance ||Sampling, monitoring, and vigilance controls in place.|
|Local Testing||Generally not required|
|Clinical Studies||Required for: Implantable, novel products and materials, modified devices.|