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Technical File Overview

What is the Technical Documentation File?​

The Technical Documentation File (TDF) — also called the Technical File — is the core submission document for MDMA applications in Saudi Arabia. It must demonstrate that the device complies with the Essential Principles of Safety and Performance and meets all applicable SFDA requirements.

The TDF must be submitted in English. It is structured in accordance with MDS-REQ 1 Annex 3 and must be kept up to date throughout the device's lifecycle.

Technical file sections (MDS-REQ 1 Annex 3 structure)​

SectionContent
1. Device descriptionName, models, catalogue numbers, intended use, indications, contraindications, patient population, intended users, classification justification
2. Manufacturer informationLegal manufacturer name/address, manufacturing site(s)
3. Essential Principles complianceChecklist or matrix referencing how each applicable principle is addressed; reference standards applied
4. Risk managementISO 14971 risk management report and summary
5. Design and manufacturingTechnical drawings, specifications, materials, manufacturing process description
6. Performance and safety testingTest reports: biocompatibility (ISO 10993), sterility, EMC, electrical safety, mechanical testing, shelf-life/stability
7. Clinical evaluationClinical Evaluation Report (CER) or equivalence-based clinical evidence
8. Labelling and IFUAll labels, IFU, packaging artwork (English; Arabic for home-use)
9. Post-market surveillance planPMS/PMCF strategy
10. Declaration of ConformitySigned statement per Annex 14 template
11. Additional annexesAs applicable: sterility validation, measuring function, reusable device reprocessing

Key SFDA-specific documents​

Declaration of Conformity — Annex 14 template​

The SFDA provides a specific Declaration of Conformity (DoC) template in Annex 14 of MDS-REQ 1. The DoC must be completed and signed by the legal manufacturer using this template — generic DoC formats may not be accepted.

Reference country approval evidence​

While not a prerequisite, the SFDA requests evidence of prior approvals in reference markets (EU CE marking, FDA clearance, TGA registration, etc.) as supporting documentation. This can facilitate the review process.

Technical file language​

All technical documentation must be submitted in English. Labelling and IFU must also be in English. Home-use device labelling must additionally be provided in Arabic.

Document control and version management​

The technical file is a living document — it must be updated whenever:

  • A significant device change is made (triggering change notification or re-submission)
  • New post-market data affects the risk-benefit assessment
  • The MDMA certificate is renewed

Maintain a clear document revision history with version dates and descriptions of changes.

Further reading​