Full Saudi Arabia Market Access Kit

Everything to prepare an SFDA MDMA: score your file with the gap analysis, then build the Annex 3 technical documentation from the template.

Bought together as the Gold Kit, they save you compared with buying them separately.

What’s inside

Both Saudi Arabia kits, in one download:

• SFDA Saudi Gap Analysis — 20-sheet scored workbook, 144 items, with the DO-NOT-FILE gate.
• Saudi Arabia Technical Documentation Kit — the Annex 3 template (essential principles embedded as Section 4, GSPR-mapped), README and master index.

Why it works

• Assess, then assemble. Score the file with the gap analysis, then build the Annex 3 documentation — one coherent workflow.
• EU GSPR cross-referenced (1:1). SFDA essential principles share EU MDR Annex I numbering, so CE evidence transfers directly.
• A filing gate, not just a list. The dashboard returns DO NOT FILE while any killer item is unresolved, so you never submit an incomplete file by accident.
• Straight from the regulations. Every item is traced to the regulation, annex or guidance it comes from — not a second-hand summary.

How to use it

1. Start with the gap analysis to see where your file stands.
2. Build the Annex 3 technical documentation from the template.
3. Complete the embedded essential-principles checklist, reusing CE evidence via the GSPR mapping.
4. Resolve every killer item, then hand a filing-ready file to your Authorised Representative.

Who it’s for

• Manufacturers preparing a complete SFDA MDMA
• RA consultants who want the full Saudi toolkit in one purchase
• Teams that will reuse the method across multiple devices

What the bundle includes

• SFDA Saudi Gap Analysis — normally €149
• Saudi Arabia Technical Documentation Kit — normally €249

Bought separately these come to €398. As the Gold Kit they are €349 — a saving of €49.

Specifications

Frequently asked questions