Medical Device Marketing Authorization (MDMA)
What is MDMA?
Medical Device Marketing Authorization (MDMA) is the official approval issued by the SFDA that permits a medical device or IVD to be legally marketed, distributed, and sold in the Kingdom of Saudi Arabia. Without a valid MDMA certificate, no device may be placed on the Saudi market.
The MDMA certificate is issued in both Arabic and English and includes:
- Device name, model(s), and catalogue number(s)
- Legal manufacturer details
- AR (Authorized Representative) details
- Risk classification
- Certificate validity period (typically one to three years)
Who needs MDMA?
All medical devices and IVDs — regardless of risk class — require MDMA prior to market entry in Saudi Arabia. There are limited exceptions for:
- Devices exempt by SFDA announcement (published on the SFDA website); these require an MDIL (Medical Device Importing License) instead
- Devices used solely for research, training, or demonstration purposes
- Custom-made devices (subject to specific conditions)
The single pathway: MDMA-2 (TFA)
Since January 2022, MDMA-2 (Technical File Assessment) is the only registration route. The earlier MDMA-1 (GHTF route), which accepted reference country approvals (CE mark, FDA clearance, etc.) without full technical file review, was cancelled.
Under the TFA route:
- A complete technical file must be submitted for all device classes
- The SFDA conducts an independent evaluation — CE marking, FDA clearance, or TGA registration supports but does not substitute for SFDA review
- Prior approval in a reference country (EU, US, Canada, Australia, Japan) is no longer a prerequisite for registration
A CE certificate is not required and does not exempt a device from SFDA MDMA. However, manufacturers with existing CE marking can leverage the EU technical documentation structure, as the SFDA's technical file requirements align closely with EU MDR.
Step-by-step MDMA process
| Step | Action | Notes |
|---|---|---|
| 1 | AR appointment | AR must hold a valid SFDA AR license before submission |
| 2 | Classification | Apply MDS-REQ 1 rules; document justification in technical file |
| 3 | Technical file preparation | Follow MDS-REQ 1 Annex 3 structure |
| 4 | GHAD submission | AR (or manufacturer directly) submits via GHAD portal |
| 5 | Submission check | SFDA verifies completeness — not a content review at this stage |
| 6 | Invoice | SFDA issues invoice; payment required before technical review begins |
| 7 | Technical review | SFDA may issue queries (deficiency letters); respond via GHAD |
| 8 | MDMA certificate issued | Approval granted; device may enter the Saudi market |
MDMA validity and renewal
The MDMA certificate is typically valid for one to three years depending on device class and the nature of the application. Renewal must be submitted via GHAD before expiry. See MDMA Renewal for details.
Fees
Application fees vary by device class, complexity, and the number of items bundled in the application. The SFDA issues an invoice via GHAD after the initial submission check. Payment must be made before the substantive technical review begins.