Saudi Arabia Technical Documentation Kit

An SFDA MDMA requires technical documentation structured on Annex 3 of MDS-REQ 1 — eight sections from device description through post-market surveillance. This kit gives you that documentation as a single, structured, fill-in Word template.

The essential-principles checklist is built in as Section 4, exactly as Annex 3 requires, with each principle cross-referenced 1:1 to the matching EU MDR GSPR — so an existing CE technical file transfers directly.

What’s inside

Three files — a README, the technical documentation template and an index:

• SA-00 README — the MDMA Saudi Route, the Authorised Representative, and how to complete the file.
• SA-TD — Technical Documentation — the eight Annex 3 sections, with the essential-principles checklist embedded as Section 4 (GSPR-mapped).
• SA-IDX Master Index (Excel) — a control sheet mapping every section.

Why it works

• Straight from the regulations. Every item is traced to the regulation, annex or guidance it comes from — not a second-hand summary.
• Structured on Annex 3. Follows the eight-section Annex 3 structure of MDS-REQ 1, so the documentation reads the way an SFDA reviewer expects.
• Essential principles built in. The checklist is embedded as Section 4, with each principle cross-referenced 1:1 to the EU MDR GSPR.
• Built to be completed. Colour-coded fill-in fields, dropdowns and a clean print layout — designed to be worked in, not just read.

How to use it

1. Start from the README to understand the route and the structure.
2. Complete the eight sections of the technical documentation for your device.
3. Work through the embedded essential-principles checklist, reusing CE evidence via the GSPR mapping.
4. Track sections in the master index, delete the guidance notes and assemble for your Authorised Representative.

Who it’s for

• Manufacturers preparing an SFDA MDMA
• RA consultants building the technical documentation
• Saudi Authorised Representatives assembling the file on a manufacturer’s behalf

Specifications

Frequently asked questions