| Thai FDA | Food and Drug Administration of Thailand — regulatory authority under Ministry of Public Health |
| MDCD | Medical Device Control Division — the Thai FDA division responsible for medical device regulation |
| MoPH | Ministry of Public Health — the ministry under which Thai FDA operates |
| B.E. | Buddhist Era — Thai calendar system; B.E. = CE + 543 (e.g., B.E. 2562 = CE 2019) |
| Medical Device Act B.E. 2562 | Thailand's primary medical device legislation, in force 15 February 2021 |
| AMDD | ASEAN Medical Device Directive — the harmonised ASEAN framework implemented in Thailand |
| CSDT | Common Submission Dossier Template — the ASEAN-standard dossier format required for Class 2–4 applications |
| Class 1 | Lowest risk class — Listing pathway (Positive List only), minimal documentation |
| Class 2 | Low-moderate risk — Notification pathway |
| Class 3 | Moderate-high risk — Notification pathway |
| Class 4 | High risk — License pathway; most stringent review |
| Listing | Approval pathway for Class 1 Positive List devices; automatic listing |
| Notification | Approval pathway for Class 2 and 3 devices |
| License | Approval pathway for Class 4 devices; most comprehensive review |
| Positive List | Thai FDA-published list of Class 1 devices eligible for the Listing pathway |
| Establishment License | Mandatory operational licence for all manufacturers and importers in Thailand |
| AR | Authorized Representative — Thai-registered entity representing a foreign manufacturer to Thai FDA |
| NBTC | National Broadcasting and Telecommunications Commission — approves wireless/BT/Wi-Fi devices independently of Thai FDA |
| Concise route | Expedited evaluation pathway for devices with prior reference NRA approval |
| 5-year validity | All Thai FDA product approvals expire after 5 years and must be renewed |
| Grouping | CSDT feature allowing multiple related devices to be covered in one application (Family, System, Set, IVD Test Kit, IVD Cluster) |
| FSCA | Field Safety Corrective Action — post-market corrective action for marketed devices |