Phillipines Medical Device Regulations

Agency
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 ClassificationExamplesRisk Level
ACholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scaleLow
BPregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical MaskLow - Moderate
CBlood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lensHigh - Moderate
DHIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, PacemakerHigh
Premarket Approval Process
Class AClass BClass CClass D
Must apply for a Certificate of Medical Device Notification (CMDN)Must apply for a Certificate of Medical Device Registration (CMDR).
Submit application of notificationSubmit dossier in CSDT format
FDA will review application
If approved, FDA will issue a Notification Number.If further information is required, FDA will notify applicant and applicant must submit supplemental documents.
Documents will then be evaluated and if all are accurate, FDA will issue CMDN.Documents will then be evaluated and if all are accurate, FDA will issue CMDR.
Additional Information
ValidityOne Year
Postmarket Surveillance Sampling, monitoring, and vigilance controls in place.
Timeline6-8 months
Local TestingGenerally not required
Clinical StudiesRequired for: Implantable, novel products and materials, modified devices.
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