Glossary of medical device and quality management terms
References reviewed: October 2026
Sixty terms in Arabic with the English equivalent your documents use, each with a short meaning. The references close each section.
Glossary in English
Licensing and establishments
| Term | العربية | Meaning |
|---|---|---|
| Saudi Food and Drug Authority (SFDA) | الهيئة العامة للغذاء والدواء | The authority that licenses and oversees medical device establishments. |
| Medical Devices Law | نظام الأجهزة والمستلزمات الطبية | The law issued by Royal Decree M/54; its activities need a licence. |
| Implementing Regulation | اللائحة التنفيذية | The Implementing Regulation of the Medical Devices Law. |
| Medical Device Establishment Licence (MDEL) | ترخيص المنشأة | The SFDA licence an establishment needs before it starts its activity, covering its branches and warehouses. |
| Licensed activity | نشاط الترخيص | An activity SFDA licenses, with its own specific requirements: manufacturer, importer, distributor, authorized representative, warehouse. |
| Establishment category | فئة المنشأة | Class A, B, C or D within the import and distribution activity; it sets the path for QMS evidence. |
| Fee | المقابل المالي | Licence fees and terms by activity and class. |
| Licence renewal | تجديد الترخيص | You may apply up to 60 days before the current licence expires. |
| Establishment account | حساب المنشأة | The establishment's account in SFDA's Ghad e-system, with its establishment number. |
| Legal entity | الكيان النظامي | The legal body that makes the establishment responsible for its activities in the Kingdom. |
| Branch | الفرع | A unit belonging to a licensed main establishment, listed in its main licence. |
| Importer | المستورد | A licensed establishment that imports medical devices into the Kingdom. |
| Distributor | الموزّع | A licensed establishment that distributes medical devices within the Kingdom. |
| Authorized Representative (AR) | الممثل المعتمد | A licensed establishment that represents a foreign manufacturer in its dealings with SFDA. |
| Representation agreement | اتفاقية التمثيل | The attested agreement between a manufacturer and its AR, with minimum contents. |
| Warehouse | المستودع | An establishment licensed to store medical devices. |
| Warehouse licence | رخصة المستودع | The licence an establishment that stores devices needs, renewed before it expires. |
| Third-party storage | التخزين لدى الغير | Renting space inside a licensed warehouse, with a separate licence per space and an attested contract. |
| Sales outlet | منفذ البيع | A point of sale belonging to an import and distribution establishment, online stores included. |
| Technical manager | المدير الفني | The full-time qualified manager SFDA requires for warehouses and factories. |
Devices and the market
| Term | العربية | Meaning |
|---|---|---|
| Marketing Authorization (MA) | إذن التسويق | SFDA's authorization without which no device may circulate in the Kingdom. |
| Marketing authorization certificate | شهادة إذن التسويق | The document that must accompany every device, valid. |
| Circulation | التداول | Making a device available, free or for a price, for distribution or use. |
| Risk classification | تصنيف الخطورة | The device's own class, A, B, C or D, distinct from the establishment category. |
| Labelling | التوسيم | The information the manufacturer puts on the device and its package, including transport and storage instructions. |
| Unique Device Identification (UDI) | الترميز التعريفي الموحد | The device identification system through which the manufacturer assigns each device its code. |
| Device Identifier (DI) | معرّف الجهاز | The part of the UDI that identifies the model and device. |
| Production Identifier (PI) | معرّف الإنتاج | The part of the UDI that carries production data such as lot and serial number. |
| Saudi-DI database | قاعدة بيانات سعودي-دي آي | The database UDI data is submitted to; it must be available when the device is placed on the market. |
| Prescription devices | الأجهزة المصروفة بوصفة | High-risk devices that may be dispensed for use outside healthcare facilities only on prescription. |
| Used device | الجهاز المستعمل | A previously used device, with conditions for resale, loan or donation. |
| Conformity assessment body | جهة تقييم المطابقة | The body that verifies conformity and issues the QMS certificate. |
Import, transport and storage
| Term | العربية | Meaning |
|---|---|---|
| Import permit | إذن الاستيراد | SFDA's permit to import chemicals classified as medical devices, such as laboratory reagents, valid for one year. |
| Customs release | الفسح | SFDA's approval to clear an imported consignment, applied for before it reaches the port of entry. |
| Data logger | مسجّل البيانات | A device that records temperature and humidity in a parcel or storage area, active from shipment. |
| Temperature mapping | الخارطة الحرارية | A three-dimensional study of temperature across a storage area to find its warmest and coldest points. |
| Quarantine | العزل | Holding stock released without disposal rights, seized, returned, recalled, damaged or expired in a marked place until it is disposed of. |
| Temperature excursion | الانحراف عن ظروف التخزين | Temperature or humidity going outside the required limits; the written procedure sets what to do. |
| Cold chain | سلسلة التبريد | Keeping items that need cooling within their limits through storage and transport. |
| Contingency plan | خطة الطوارئ | A plan for power cuts to cooled or air-conditioned areas, as the alternative to a backup power generator. |
| Destruction record | محضر الإتلاف | A record of the destroyed device and why, kept for at least 3 years. |
| Withdrawal decision | قرار السحب | A decision after which importers and distributors stop importing and distributing the device. |
Reporting and inspection
| Term | العربية | Meaning |
|---|---|---|
| Vigilance | التيقظ | Reporting and investigating device incidents and complaints within set deadlines. |
| National Center for Medical Devices Reporting (NCMDR) | المركز الوطني للتبليغ عن الأجهزة الطبية | The body device incidents and reports are sent to. |
| Post-market surveillance | رقابة ما بعد التسويق | Following devices after they are placed on the market, under requirements SFDA publishes. |
| Post-market surveillance plan | خطة رقابة ما بعد التسويق | The manufacturer's plan for following its device, part of the technical file. |
| Inspection | التفتيش | SFDA's visit to verify an establishment's quality management system. |
| Inspection report | تقرير التفتيش | The report SFDA issues after a visit: within 10 working days for establishments, 15 for factories. |
| Corrective action plan | خطة الإجراءات التصحيحية | The plan an establishment submits in response to inspection findings, with up to three chances to amend it. |
| Traceability | التتبع | The ability to trace a device by lot or serial number from supply to use. |
Quality management system
| Term | العربية | Meaning |
|---|---|---|
| Quality management system | نظام إدارة الجودة | The system an establishment proves under SFDA.MD/GSO ISO 13485:2017. |
| Quality manual | دليل الجودة | The document that sets the system's scope and exclusions and refers to its procedures. |
| Medical device file | ملف الجهاز الطبي | A file for each device or device family that gathers its documents. |
| Control of documents | ضبط الوثائق | Reviewing, approving, issuing and changing documents in a controlled way. |
| Control of records | ضبط السجلات | Keeping and retrieving records and their retention periods. |
| Management review | مراجعة الإدارة | Top management's review of the quality system at planned intervals. |
| Internal audit | التدقيق الداخلي | The establishment's audit of its own system at planned intervals. |
| Corrective action | الإجراء التصحيحي | Action to remove the cause of a nonconformity and prevent it recurring. |
| Nonconforming product | المنتج غير المطابق | Product that does not meet its requirements, identified and controlled until disposition. |
| Risk management | إدارة المخاطر | Identifying, evaluating and controlling a device's risks. |
References
| Number | Official name | Link | Last updated |
|---|---|---|---|
| MDS-REQ-009 | Requirements for Licensing of Medical Devices Establishments | https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-REQ%209_En_V2.pdf | 2025-01-15 |
| Royal Decree M/54 | Medical Devices Law | https://laws.boe.gov.sa/BoeLaws/Laws/LawDetails/9daec1bf-6bda-4a65-a111-ace90163af7e/1 (Arabic) | Not stated |
| (3-29-1443) | Implementing Regulation of the Medical Devices Law | https://www.sfda.gov.sa/sites/default/files/2023-10/MDSysExcE.pdf | Not stated |
| MDS-REQ-012 | Requirements on Transporting and Storage for Medical Devices | https://www.sfda.gov.sa/sites/default/files/2026-08/MDS-REQ12E_0.pdf | 2024-12-15 |
| MDS-REQ-001 | Requirements for Medical Devices Marketing Authorization | https://www.sfda.gov.sa/sites/default/files/2021-12/REQ1En_0.pdf | 2021-12-19 |
| MDS-G008 | Guidance on Medical Devices Classification | https://www.sfda.gov.sa/sites/default/files/2022-12/MDS%E2%80%93G008.pdf | 2022-12-13 |
| MDS-REQ-007 | Requirements for Unique Device Identification (UDI) of Medical Devices | https://www.sfda.gov.sa/sites/default/files/2022-06/RequirementsUDI_0.pdf | 2022-05-24 |
| MDS-REQ-010 | Requirements for Inspections and Audit of Quality Management System (QMS) on Medical Devices Manufacturers and Establishments | https://www.sfda.gov.sa/sites/default/files/2026-08/MDS-REQ10E.pdf | Not stated |
| — | List of Medical Devices Requiring a Prescription | https://www.sfda.gov.sa/sites/default/files/2022-06/MDPrescriptionList.pdf | Not stated |
| MDS-REQ-011 | Requirements for Post-Market Surveillance of Medical Devices | https://www.sfda.gov.sa/sites/default/files/2023-05/MDS_REQ%2011_V2_En.pdf | 2023-03-23 |
| MDS-REQ-005 | Requirements on Importation and Shipments Clearance of Medical Devices | https://www.sfda.gov.sa/sites/default/files/2023-07/MDS-REQ5E.pdf | 2023-07-19 |
| SFDA.MD/GSO ISO 13485:2017 | Saudi standard SFDA.MD/GSO ISO 13485:2017 — Medical devices: quality management systems | — | Not stated |
| ISO 14971 | ISO 14971 — Application of risk management to medical devices | — | — |