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 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
Premarket Approval Process
Class A Class B Class C Class D
Must apply for a Certificate of Medical Device Notification (CMDN) Must apply for a Certificate of Medical Device Registration (CMDR).
Submit application of notification Submit 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
Validity One Year
Postmarket Surveillance Sampling, monitoring, and vigilance controls in place.
Timeline 6-8 months
Local Testing Generally not required
Clinical Studies Required for: Implantable, novel products and materials, modified devices.
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