Technical Documentation & Essential Principles (SFDA)

Technical Documentation Must Demonstrate Safety and Performance — Not Merely Contain Reports. SFDA reviews the technical file as evidence that the device is designed, manufactured and controlled to meet applicable safety and performance requirements. The file should connect intended purpose, risk management, verification and validation, clinical or performance evidence, labeling and post-market controls.

Review Your Saudi Technical File

When This Support Is Needed

Compiling a complete technical file for Class A, B, C, or D MDMA authorization under MDS-REQ 1

Adapting an existing EU MDR/IVDR technical file or US FDA 510(k)/PMA dossier for Saudi Arabia

SFDA has issued an official deficiency notice questioning pre-clinical, clinical, or testing evidence

Establishing robust traceability between risk mitigations, test reports, and Arabic/English IFU claims

What We Challenge Before Submission

Is the tested device configuration identical to the finished commercial article to be marketed in Saudi Arabia?

Do pre-clinical laboratory reports substantiate the exact clinical claims made in the Arabic/English IFU?

Are test standards and editions current, fully harmonized, and recognized by the SFDA?

Are worst-case product selection rationales scientifically defended in mechanical and biological test reports?

Do all risk control measures in the risk management file have corresponding, verified test evidence?

Technical File Components We Compile & Review

Device description, technical specifications, and intended medical purpose documentation

Design and manufacturing process flows, critical supplier controls, and site information

SFDA Essential Principles of Safety and Performance evidence mapping checklist

Risk management file and benefit-risk analysis documentation under ISO 14971

Biological evaluation and biocompatibility testing evidence (ISO 10993)

Sterilization validation and microbiological barrier integrity reports

Packaging qualification, transit simulation, and real-time/accelerated shelf-life evidence

Electrical safety and Electromagnetic Compatibility (EMC) testing reports (IEC 60601)

Software lifecycle documentation, architecture, and cybersecurity verification (IEC 62304)

Usability and human factors engineering documentation (IEC 62366-1)

Clinical evaluation reports (CER), clinical investigation data, and literature reviews

IVD analytical performance (LoD, LoQ, linearity, precision) and clinical concordance data

Bilingual Arabic and English labeling, packaging artwork, and IFU consistency review

Post-market surveillance plans and lifecycle documentation update governance

Traceability Chain:

We trace Intended Purpose -> Classification -> Essential Principles -> Risk -> Verification / Validation -> Clinical or Performance Evidence -> Labeling. A report may be technically sound but still fail to support the Saudi submission if the tested configuration, claims or acceptance criteria do not match the marketed device.

Harmonize Your Technical File with SFDA Essential Principles

Our regulatory engineers compile MDS-REQ 1 technical documentation, map evidence matrices, and review pre-clinical data.

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