| MDACS | Medical Device Administrative Control System — HK's device framework |
| MDD | Medical Device Division, Department of Health — the competent authority |
| MDIS | Medical Device Information System — online listing database and submission portal |
| HKMD number | Unique listing number issued upon MDACS approval |
| LRP | Local Responsible Person — HK-based entity accountable for listing and post-market obligations |
| AMD | Applicable Medical Device — Class II/III/IV or IVD B/C/D; subject to DH procurement mandate |
| IMDRF | International Medical Device Regulators Forum — framework basis for MDACS |
| Essential Principles | Safety and performance requirements in TR-001 |
| Expedited Scheme | Fast-track listing relying on reference-country approval |
| FSCA | Field Safety Corrective Action — action to reduce risk from a marketed device |
| FSN | Field Safety Notice — user communication about an FSCA |
| TR | Technical Reference — MDD normative documents |
| GN | Guidance Note — MDD procedural guidance |
| SaMD | Software as a Medical Device |