FDA Requirements for the Issuance of an Authorization for the Sale, Manufacture, Importation or Distribution of a Medical Device in the Philippines
What is a medical device? The regulations issued by the Food and Drug Administration (FDA) of the Philippines defined a ‘medical device’ as 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
