Forms, Fees & SFDA Submission Portals
The GHAD portal — primary submission platform
All SFDA medical device regulatory submissions are made through the GHAD portal (Unified Electronic System). This includes:
| Submission type | Via GHAD? |
|---|---|
| MDMA application (new) | ✅ Yes |
| MDMA renewal | ✅ Yes |
| MDMA variation / change notification | ✅ Yes |
| MDEL application | ✅ Yes |
| MDEL renewal | ✅ Yes |
| UDI data submission | ✅ Yes |
| Adverse event reporting (NCMDR) | ✅ Yes |
| Advertising pre-approval | ✅ Yes (or dedicated channel — verify) |
→ GHAD portal: ghad.sfda.gov.sa (verify current URL on SFDA website)
Key SFDA forms
Declaration of Conformity — Annex 14 (MDS-REQ 1)
The Declaration of Conformity template is found in Annex 14 of MDS-REQ 1. This must be completed using the SFDA's template, not a generic or EU-format DoC.
Download from: SFDA website → Medical Devices → Guidance Documents → MDS-REQ 1 → Annex 14
MDEL application forms
MDEL application forms are completed within the GHAD portal — there are no separate downloadable forms; the system guides the applicant through required fields.
Adverse event report form
Adverse event reports (to NCMDR) are submitted via GHAD or through the NCMDR dedicated reporting channel on the SFDA website.
Application fees
SFDA fees for MDMA and MDEL applications vary by:
- Device risk class (Class A → D)
- Number of devices in a grouped application
- Type of establishment license (AR, importer, distributor, manufacturer)
The SFDA invoices the applicant via GHAD after the initial submission completeness check — fees must be paid before technical review begins. Fee schedules are published on the SFDA website and are subject to change.
Fee amounts change periodically. Always check the current SFDA fee schedule on the official website or confirm with your AR before budgeting for a submission.
SFDA e-Services website
In addition to GHAD, the SFDA e-Services website provides access to:
- SFDA announcements and regulatory updates
- Published MDMA certificate status lookup
- Guidance document downloads
- Contact forms for general regulatory enquiries
→ SFDA website: www.sfda.gov.sa
Review timelines — quick reference
See SFDA Review Timelines for indicative review periods by device class.