MDMA Certificate: The Complete Guide to Medical Device Imports

MDMA = Medical Device Marketing Authorization

A mandatory SFDA certificate for any medical device marketed in the Kingdom. Obtaining it can take 3 to 12 months depending on the device class.

The Difference Between MDMA and MDIL

Certificate	Use	Duration
MDMA	Device registration for commercial marketing	3–12 months
MDIL	Import for limited use (training/exhibitions)	1–3 weeks

Medical Device Classes in SFDA

Devices are classified by risk to the patient:

Class A — Low Risk

• Medical gauze, bandages, simple measurement tools
• MDMA duration: 3–4 months

Class B — Low-Medium Risk

• Blood pressure monitors, non-sterile syringes
• MDMA duration: 4–6 months

Class C — Medium-High Risk

• X-ray machines, simple surgery tools, contact lenses
• MDMA duration: 6–9 months

Class D — High Risk

• Life-support devices, implantables
• MDMA duration: 9–12 months

Documents Required for MDMA

1. Saudi establishment license (importer/distributor)
2. Authorized legal representative in the Kingdom (mandatory for foreign manufacturer)
3. GMP certificates from the manufacturer (Good Manufacturing Practice)
4. CE certificate or FDA (depending on country)
5. ISO 13485 certificate for quality management
6. Technical reports (Technical File)
7. Clinical studies (for Classes C and D)

Steps in Order

1. Establish the Entity in SFDA

• Register the company as a medical device importer
• Authorize the legal representative (mandatory for foreign manufacturer)
• License the medical warehouse

2. Register the Device

• Submit the complete technical file
• Pay registration fees
• Technical review by SFDA

3. Evaluation

• Review safety and efficacy
• Additional tests if requested
• Surprise visit to the device manufacturer (for high classes)

4. Issue MDMA

• Authorization for 5 years (renewable)
• Linked to the SFDA-Track electronic tracking system

When to Use MDIL Instead of MDMA

MDIL is simpler and faster, but for limited cases:

✅ Use MDIL for:

• Display devices in medical exhibitions
• Training equipment in institutes
• Importing one device for research
• Replacing an existing device (same model)

❌ Don’t use MDIL for:

• Commercial sale to hospitals
• Repeated bulk imports
• Public distribution

MDMA Fees (Approximate)

• Class A: ~SAR 5,000
• Class B: ~SAR 10,000
• Class C: ~SAR 25,000
• Class D: ~SAR 50,000

Fees do not include extra lab tests or SFDA visits to the manufacturer.

Golden Tips

1. Start early: 12 months before commercial marketing
2. Choose an expert legal representative: don’t pick the cheapest
3. Prepare a complete technical file from the start: gaps delay months
4. Keep up with SFDA continuously: don’t go silent

OBOOR’s Tip

OBOOR handles:

• Registering your facility in SFDA
• Preparing a complete MDMA file
• Direct follow-up with SFDA
• Clearing shipments after issuance

Book a free medical consultation — we review your device and identify the right path.