MDS-REQ Guidance Series
What are MDS-REQ documents?
MDS-REQ documents are the SFDA's official requirements guidance series for medical devices. They translate the Medical Devices Law and Implementing Regulation into practical, actionable compliance requirements. The MDS-REQ series is the primary reference for day-to-day regulatory compliance in Saudi Arabia.
MDS-REQ document index
| Document | Topic | Key content |
|---|---|---|
| MDS-REQ 1 | Requirements for MDMA | Classification rules, technical file structure (Annexes 1–14), MDMA application process |
| MDS-REQ 2 | Essential Principles of Safety and Performance | List of all applicable Essential Principles for devices and IVDs |
| MDS-REQ 3 | Quality Management Systems | ISO 13485 requirements, CAB accreditation, QMS scope |
| MDS-REQ 4 | Clinical Evaluation | CER requirements, evidence thresholds by class, PMCF |
| MDS-REQ 5 | Post-Market Surveillance and Vigilance | PMS Report, PSUR, adverse event reporting, FSCA requirements |
| MDS-REQ 6 | Medical Device Establishment License | MDEL types, eligibility, application process |
| MDS-REQ 7 | Unique Device Identification (UDI) | UDI structure, data submission, labelling requirements |
| MDS-REQ 8 | Medical Device Advertising | Pre-approval requirements, permitted/prohibited claims |
| MDS-REQ 9 | Authorized Representative | AR obligations, AR license requirements |
MDS-G guidance documents
The MDS-G series provides supplementary technical guidance:
- MDS-G008 — Classification guidance (interpretation of classification rules)
- MDS-G on SaMD and digital health
- MDS-G on labelling and IFU
- MDS-G on specific device types
MDS-G documents are reference guides rather than binding requirements, but non-compliance with their guidance creates regulatory risk.
Accessing MDS-REQ documents
MDS-REQ and MDS-G documents are published on the SFDA website (medical devices section → guidance documents). They are the primary English-language compliance reference for foreign manufacturers navigating the Saudi market.