Medical Device Marketing Authorization (MDMA)
MDMA is the official approval granted by the Saudi FDA that allows companies to
market and sell medical devices and In-Vitro Diagnostics (IVDs) in Saudi Arabia.
It ensures your products meet required quality and safety standards before being
introduced to the market.
MDMA is mandatory for selling medical devices and IVDs in Saudi Arabia.
MDMA Process with Regulatory Standards
- Step 1 – Document Review:
We meticulously assess your documents for compliance with Saudi FDA requirements.
- Step 2 – Translation Assistance:
We advise on required translations. (English is preferred; Arabic is required only for home use/Lay person products.)
- Step 3 – Saudi FDA Submission:
We handle the entire online application submission.
- Step 4 – Saudi FDA Communication:
We represent you throughout the Saudi FDA review process.
Benefits of MDMA Approval
- Market Access:
Legally sell medical devices in the Saudi Arabian market.
- Credibility:
Demonstrate adherence to quality standards and regulatory compliance.
- Growth Potential:
Tap into a fast-growing and profitable healthcare market.
Service Details:
Timeline
New MDMA Application: 40 - 60 Working days from submission to approval.
Renewal / Update Application:40 - 60 Working days from submission.
Renewal/Update
- Renewal:
Can be initiated 90 days (3 months) prior to the current MDMA license’s expiry. Note: New products CANNOT be added during renewal.
- Update (Minor/Major):
Can be submitted any time to notify the SFDA of changes in documentation or to add models/products to an existing application.
Validity
- New MDMA Certificate:
Valid for 3 years if obtained through the Technical File Assessment (TFA) route.
- Medium/High-Risk Devices:
Validity is up to 3 years, subject to the validity of associated conformity certificates from recognized international bodies (if less than 3 years).
- Renewal Validity:
Starts from the expiry date of the previous certificate.
