Registering a Class C medical device in Saudi Arabia involves complying with the regulatory framework established by the Saudi Food and Drug Authority (SFDA). Here's a step-by-step guide on how to handle the registration, including requirements, procedures, timelines, and practical tips.

✅ 1. Understand the Regulatory Authority

Regulatory Body:
Saudi Food and Drug Authority (SFDA)
Website: https://sfda.gov.sa

Regulation:
SFDA operates under the Medical Devices Interim Regulation, and all medical devices must be registered in the MDMA (Medical Device Marketing Authorization) system.

Classification:
Class C devices are moderate-to-high risk devices (e.g., infusion pumps, bone fixation plates, etc.), subject to more detailed regulatory scrutiny.

✅ 2. Appoint a Saudi Authorized Representative (AR)

Why?

If you are a foreign manufacturer, you must appoint a local Saudi Authorized Representative to interface with the SFDA.

Key responsibilities of the AR:

• Communicating with SFDA on your behalf

• Submitting documentation

• Handling adverse event reporting and recalls

• Ensuring post-market compliance

✅ 3. Obtain Establishment Licensing

For both Manufacturer and AR:

• Establishment License (EL): Required for all entities involved in importing, distributing, or marketing medical devices.

• The EL must be obtained via the GHAD System on the SFDA platform.

✅ 4. Device Classification Confirmation (Optional but Recommended)

You can submit a classification consultation request to SFDA to confirm your device is indeed Class C. This ensures you're applying through the correct regulatory pathway.

✅ 5. Submit Medical Device Marketing Authorization (MDMA)

Key Steps:

1. Prepare the Required Technical Documentation:

   • Description and intended use of the device

   • Classification rationale

   • Risk management documentation (ISO 14971)

   • Clinical evaluation report (CER) or literature

   • Post-market surveillance plan

   • Labeling and Instructions for Use (Arabic and English)

   • Manufacturing Quality Management Certificate (ISO 13485)

   • Free Sale Certificate from country of origin

   • Declaration of Conformity

2. Submit Through SFDA MDMA Portal:

   • Upload documents

   • Provide device identifiers (e.g., GMDN/UDI codes)

   • Pay the registration fee (see below)

3. Undergo Technical File Review:

   • SFDA will evaluate compliance with applicable GHTF, IMDRF, and Saudi requirements.

✅ 6. Pay Fees

Fees depend on the risk class and number of devices:

• For Class C: Generally around 8,000–15,000 SAR (approx. $2,000–$4,000 USD) per device configuration.

• Check the exact fee structure on SFDA’s fee schedule.

✅ 7. Await SFDA Review and Approval

Timeframe:

• Typically 4–6 months, depending on completeness of submission and SFDA workload.

Outcome:
Once approved, you will receive a Medical Device Marketing Authorization (MDMA) license.

✅ 8. Post-Market Obligations

Once approved, you must comply with:

• Vigilance reporting (reporting adverse events and incidents)

• Annual update/reporting

• Post-market surveillance and possibly local clinical studies

• Renewal of MDMA License before expiry (valid for 3 years typically)

✅ Required Documents (Summary Checklist)

✅ Tips for a Smooth Registration

• Use a local consultant or AR experienced with SFDA to avoid common errors.

• Ensure that your documentation matches GHTF/IMDRF formats (SFDA is a GHTF member).

• Translate all labeling and IFU into Arabic per local regulations.

• Consider leveraging existing approvals (FDA 510(k), CE, TGA) to support your submission.

✅ Common Pitfalls to Avoid

• Submitting outdated ISO or CE certificates

• Not using the correct GMDN/IMDRF coding

• Misclassifying the device (Class C vs B/D)

• Incomplete Arabic translation of labeling

• Delays in payment or technical responses

✅ Summary: Timeline Overview

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