| AR / LAR | Authorized Representative / Local Authorized Representative — a Saudi-licensed entity appointed by a foreign manufacturer to liaise with the SFDA and hold the MDMA certificate |
| CAB | Conformity Assessment Body — an SFDA-accredited certification body authorised to certify QMS to ISO 13485 |
| CAPA | Corrective and Preventive Action — a quality system tool for addressing non-conformities |
| Class A / B / C / D | SFDA risk-based classification for medical devices; Class A is lowest risk, Class D is highest |
| Declaration of Conformity | Document signed by the legal manufacturer declaring the device complies with applicable SFDA Essential Principles (Annex 14 of MDS-REQ 1 provides the template) |
| DI | Device Identifier — the fixed portion of a UDI that identifies the device model |
| FSCA | Field Safety Corrective Action — action taken to reduce a risk of serious harm from a device already placed on the market (includes recalls) |
| FSN | Field Safety Notice — communication issued to users/healthcare providers about an FSCA |
| GCC | Gulf Cooperation Council — regional economic union comprising Saudi Arabia, UAE, Bahrain, Kuwait, Oman, and Qatar |
| GHAD | SFDA's Unified Electronic System (portal) for all medical device regulatory submissions including MDMA, MDEL, UDI, and adverse event reporting |
| GHWP | Global Harmonization Working Party — SFDA chairs this group focused on regulatory harmonisation |
| GSO | Gulf Standards Organisation — issues GCC-wide standards; SFDA uses SFDA.MD/GSO ISO 13485 |
| IAF | International Accreditation Forum — global accreditation network; IAF-accredited CBs may certify QMS in lieu of SFDA CABs in some circumstances |
| IFU | Instructions for Use — part of device labelling required in English (and Arabic for home-use devices) |
| IMDRF | International Medical Device Regulators Forum — global regulatory forum; SFDA is a member |
| IVD | In Vitro Diagnostic — a medical device used to examine specimens derived from the human body |
| KSA | Kingdom of Saudi Arabia |
| MDEL | Medical Device Establishment License — licence issued by SFDA to manufacturers, importers, distributors, and ARs operating in Saudi Arabia |
| MDIL | Medical Device Importing License — applies to certain exempted device categories not requiring full MDMA |
| MDMA | Medical Device Marketing Authorization — the approval certificate required to market a medical device in Saudi Arabia |
| MDMA-1 | Legacy GHTF-route registration (cancelled January 2022); accepted reference country approvals |
| MDMA-2 / TFA | Current single registration pathway (since 2022); requires full Technical File Assessment |
| MDS-G | SFDA guidance document series (e.g. MDS-G008 — classification guidance) |
| MDS-REQ | SFDA requirements document series (e.g. MDS-REQ 1 — MDMA requirements; MDS-REQ 7 — UDI) |
| NCMDR | National Centre for Medical Device Reporting — the SFDA unit that receives adverse event reports and vigilance data |
| PI | Production Identifier — the variable portion of a UDI identifying the specific unit (lot/batch, serial number, expiry date) |
| PMCF | Post-Market Clinical Follow-up — structured ongoing collection of clinical data for marketed devices |
| PMS | Post-Market Surveillance — the systematic process of collecting and analysing post-market data |
| PMS Report | Required for Class A devices — summarises PMS data and any CAPAs taken |
| PSUR | Periodic Safety Update Report — required for Class B, C, and D devices; frequency varies by class |
| QMS | Quality Management System — must be certified to ISO 13485 / SFDA.MD/GSO ISO 13485 |
| SaMD | Software as a Medical Device — software with a medical intended purpose regulated as a medical device |
| SFDA | Saudi Food and Drug Authority — the national competent authority for medical devices in Saudi Arabia |
| TFA | Technical File Assessment — the current single MDMA registration pathway requiring submission of complete technical documentation |
| UDI | Unique Device Identification — a system for labelling and tracking devices through distribution and use |