SFDA Saudi Arabia medical device registration
Saudi Arabia closed its shortcut. Until 2021 an approval from the EU, the US, Canada, Japan or Australia could carry a device into the Kingdom; since January 2022 the Technical File Assessment is the only route, and the SFDA reads the file itself. Every device needs a Medical Device Marketing Authorization. MD Regulatory gives you the documentation to prepare that submission correctly, the first time.
Saudi Arabia documentation kits
Prepared against MDS-REQ-001 and the SFDA implementing rules.
A prepared submission, not a guess
Our kits are built from the SFDA requirements themselves — not summaries — and mirror the technical file the Assessment route actually reads.
How registration works
Six steps from classification to market. The MD Regulatory kits carry steps 3 and 4.
Steps in magenta are where the MD Regulatory kits do the heavy lifting.
Two levels of technical file
Since January 2022 there is only one route into the Kingdom. What changes is how much file it wants.
Abbreviated file
Full technical file (TFA)
What documentation is required
All documents are submitted in English, through the AR, on the GHAD system.
Regulatory and legal
Technical
Prepared once, filed right
That is exactly the file the kits already carry — the MDS-REQ-001 structure, the essential principles and the technical file templates. So the file your AR submits is the file the SFDA expects.
See the Saudi Arabia kitsNot sure which kit — or want it done for you?
We can help you choose the right kit, review your completed file, or take on the full SFDA submission as a consulting engagement.
Common questions
Ready to prepare your SFDA file?
Start with the gap analysis, or take the complete Saudi Arabia bundle.