Technical File Overview
Structure and content requirements for the SFDA Technical Documentation File (TDF) under MDS-REQ 1 Annex 3.
Essential Principles of Safety & Performance
The SFDA's Essential Principles of Safety and Performance — what they require and how to demonstrate compliance in the technical file.
Risk Management (ISO 14971)
SFDA risk management requirements for medical devices — ISO 14971, the risk management file, and what the SFDA expects in the technical file.
Clinical Evaluation
SFDA clinical evaluation requirements — what data is needed by device class, the Clinical Evaluation Report, and use of overseas clinical data.
Labelling & IFU Requirements
SFDA labelling and Instructions for Use (IFU) requirements — content, language, and the Arabic requirement for home-use devices.
Declaration of Conformity
The SFDA Declaration of Conformity (DoC) — Annex 14 template, who signs it, and what it must include.