SFDA vs Other Regulators
Structural comparison
| Feature | SFDA (Saudi Arabia) | EU MDR | US FDA | TGA (Australia) | HSA (Singapore) |
|---|---|---|---|---|---|
| Classification | A, B, C, D (= EU I, IIa, IIb, III) | I, IIa, IIb, III | I, II, III | I, IIa, IIb, III | A, B, C, D |
| Registration | MDMA (TFA) | CE marking + Notified Body | 510(k) / PMA / De Novo | ARTG inclusion | MDACS |
| In-country rep | AR required | EU AR (non-EU mfrs) | US Agent | Sponsor | Local Authorised Rep |
| QMS | ISO 13485 (CAB/IAF) | ISO 13485 (EU NB or SFDA equivalent) | 21 CFR Part 820 / QMSR | ISO 13485 | ISO 13485 |
| Reference country | Not required for TFA | N/A | N/A | N/A | Recognised markets pathway |
| Portal | GHAD | EUDAMED | eSTAR / CDRH | TGA eBusiness | MEDICS/Prism |
Key SFDA-specific differences
- No CE equivalence — CE marking cannot substitute for MDMA; the SFDA independently evaluates all devices
- AR holds MDMA — unlike EU MDR where the manufacturer is the certificate holder, in Saudi Arabia the AR/LAR holds the MDMA certificate
- Arabic labelling — mandatory for home-use devices; no equivalent in most other markets
- Advertising pre-approval — SFDA requires pre-approval of promotional materials; this is not standard in EU or US
- MDEL required for all operators — distributors and importers must hold MDEL and ISO 13485; a broader requirement than most markets