| NMRA | National Medicines Regulatory Authority — Sri Lanka's regulatory body for medicines, devices, and related products |
| NMRA Act | NMRA Act No. 5 of 2015 — the primary legislation establishing NMRA and its powers |
| MAH | Marketing Authorization Holder — Sri Lanka-based entity with full regulatory accountability for a registered device |
| MDEC | Medical Devices Evaluation Committee — expert advisory body reviewing Class IIb/III applications |
| Registration Certificate | Step 1 approval — confirms device meets NMRA safety and performance requirements |
| Import Licence | Step 2 approval — authorises commercial importation of a registered device |
| Sample Import Licence | Temporary permit to import samples required for registration (e.g., for local testing) |
| F-MDR-035 | NMRA's Consolidated Dossier Submission Checklist — mandatory format for all new device registration applications |
| Consolidated Dossier | Single all-in-one submission package covering all registration requirements, per F-MDR-035 |
| Reliance Pathway | Fast-track registration pathway leveraging prior approval from accepted reference countries (from Oct 2025) |
| SMF | Site Master File — manufacturing facility documentation submitted for NMRA site registration |
| SRA | Stringent Regulatory Authority — reference country regulator (FDA, TGA, MHRA, EMA, etc.) |
| WHO PQ | World Health Organization Pre-Qualification — alternative route for NMRA audit waiver |
| GDPMD | Good Distribution Practice of Medical Devices — distribution quality standards |
| FSCA | Field Safety Corrective Action — action to reduce risk from a marketed device |
| FSN | Field Safety Notice — user communication issued in connection with an FSCA |
| PSUR | Periodic Safety Update Report — systematic post-market safety summary |
| PMCF | Post-Market Clinical Follow-Up — post-registration clinical data collection |
| AEA | Atomic Energy Authority of Sri Lanka — separate approving body for radiation-emitting devices |
| USD rate | NMRA annual fees are denominated in USD; converted to LKR at the rate published monthly on the NMRA website |