| FDA Philippines | Food and Drug Administration of the Philippines — regulatory authority under Department of Health |
| CDRRHR | Center for Device Regulation, Radiation Health and Research — FDA center responsible for medical devices |
| DoH | Department of Health — the ministry under which FDA Philippines operates |
| RA 9711 | Republic Act 9711 — Food and Drug Administration Act of 2009; primary legislation establishing FDA Philippines |
| CMDN | Certificate of Medical Device Notification — approval certificate for Class A (low-risk) devices |
| CMDR | Certificate of Medical Device Registration — approval certificate for Class B, C, and D devices |
| LTO | License to Operate — mandatory operational licence for all manufacturers, importers, distributors, and traders of medical devices |
| Class A | Lowest risk class — CMDN pathway |
| Class B | Low-moderate risk — CMDR pathway |
| Class C | Moderate-high risk — CMDR pathway |
| Class D | High risk — CMDR pathway; most stringent documentation |
| AMDD | ASEAN Medical Device Directive — the harmonised ASEAN framework implemented in Philippines |
| CSDT | Common Submission Dossier Template — required for CMDR (Class B/C/D) applications |
| Abridged Pathway | FDA Circular 2022-008 — 30 working-day registration for devices approved by an ASEAN NRA |
| LOA | Letter of Authorization — mandatory document from foreign manufacturer authorising the Philippine license holder, with notarised declaration |
| FSC | Free Sale Certificate — certificate from country of manufacture confirming device is legally sold there |
| FSCA | Field Safety Corrective Action — post-market corrective action for marketed devices |
| eReport | FDA Philippines online adverse event reporting system |
| 90-day rule | Applicants have 90 calendar days to address application deficiencies before the application is deemed abandoned |
| IVD | In Vitro Diagnostic — currently exempt from CMDN/CMDR registration in the Philippines (as of May 2026) |
| Regional Field Offices | FDA Philippines offices in regions outside Metro Manila — conduct local compliance monitoring |
| BOC | Bureau of Customs — coordinates with CDRRHR on importation control of unregistered devices |