SFDA Saudi Gap Analysis

A Medical Device Marketing Authorization (MDMA) via the SFDA Saudi Route means demonstrating conformity across the requirements of MDS-REQ 1 — essential principles, technical documentation, clinical, QMS, the Authorised Representative and more.

This workbook scores your file against every one of them. Mark each item, record your evidence, and a live dashboard shows whether the file is ready — and whether any killer item still blocks the authorization.

What’s inside

20 worksheets, 144 evaluable requirements, one Excel file:

• Instructions and Class & Route — Class A–D and the MDMA Saudi Route.
• Dashboard — live counts and the DO-NOT-FILE gate.
• Killer items — including the Authorised Representative and ISO 13485 prerequisites.
• Requirement sheets — essential principles, technical documentation, clinical, QMS, labelling, vigilance, UDI and more.
• Client questions & References — what to ask, and the regulatory register behind every item.

Why it works

• 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.
• EU GSPR cross-referenced. Essential requirements point to the matching EU MDR GSPR, so you can locate and reuse evidence from an existing CE technical file.
• Straight from the regulations. Every item is traced to the regulation, annex or guidance it comes from — not a second-hand summary.
• 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. Confirm the device class and route on the Class & Route sheet.
2. Score each requirement Yes / No / Partial / N/A and record your evidence.
3. Watch the dashboard flag gaps and killer items in real time.
4. Resolve every blocker, then hand a clean, filing-ready file to your local representative.

Who it’s for

• Manufacturers preparing a first SFDA MDMA
• RA consultants who want a rigorous, ready-made scaffold
• Saudi Authorised Representatives assembling a file on a manufacturer’s behalf
• QA/RA teams pressure-testing a file before it goes in

Specifications

Frequently asked questions