Registering a Class C medical device in Saudi Arabia requires navigating the regulatory framework established by the Saudi Food and Drug Authority (SFDA). Class C represents moderate-to-high risk devices, meaning the registration procedure is more rigorous than for lower classes.

Below is a detailed breakdown of the procedures and steps to register a Class C medical device in Saudi Arabia:

🧾 Step-by-Step Procedure for Class C Medical Device Registration in Saudi Arabia

✅ Step 1: Determine Device Classification

• Purpose: Confirm your device is a Class C medical device under SFDA classification rules.

• How: Use SFDA’s classification tool or refer to IMDRF/GHTF guidance.

• Optional: You may submit a classification request to SFDA for confirmation if uncertain.

✅ Step 2: Appoint an Authorized Representative (AR)

Required if the manufacturer is not based in Saudi Arabia.

• The AR must be based in Saudi Arabia and registered with SFDA.

• The AR handles communication, registration, post-market surveillance, and adverse event reporting.

• A formal Legal Representation Agreement (LRA) is required between the manufacturer and AR.

✅ Step 3: Obtain Establishment License (EL)

For both the Manufacturer and the AR (or Importer):

• Register via the GHAD system on SFDA’s website.

• Submit:

  • Commercial Registration Certificate

  • ISO 13485 certificate

  • Organization chart

  • AR agreement

  • QMS documents

• Result: SFDA issues an Establishment License, which is required for continuing the device registration process.

✅ Step 4: Prepare the Technical Documentation

As per SFDA and IMDRF/GHTF format. Your documentation must include:

✅ Step 5: Submit the MDMA (Medical Device Marketing Authorization) Application

• Log in to the GHAD or MDMA Portal: https://ghad.sfda.gov.sa

• Upload all technical documents

• Provide device details: GMDN code, model numbers, intended use, etc.

• Pay the applicable registration fee (typically SAR 8,000–15,000 per device family)

• Choose submission format: Full Review (new devices) or Abridged Pathway (for CE-marked or FDA-cleared devices)

✅ Step 6: SFDA Review and Evaluation

• Review includes:

  • Technical evaluation

  • Verification of risk classification

  • Clinical data and safety

  • Labeling and IFU compliance

• Timeline: Typically 3–6 months

• SFDA may request clarifications or additional documents.

✅ Step 7: Approval and Issuance of MDMA Certificate

• If approved, SFDA issues the Medical Device Marketing Authorization (MDMA) certificate.

• This certificate allows legal sale, importation, and distribution of the device in Saudi Arabia.

• Validity: Typically 3 years

✅ Step 8: Importation & Distribution

• Once the MDMA is obtained, the product can be imported using the SFDA’s Importation System (e.g., DAD system).

• The AR or licensed importer handles import documentation, customs clearance, and logistics.

✅ Step 9: Post-Market Surveillance (PMS) and Vigilance

After approval, you must:

• Monitor product performance in the field

• Report adverse events and incidents to SFDA via the vigilance system

• Maintain PMS records

• Conduct recalls or field safety corrective actions (FSCA) if necessary

• Renew the MDMA before expiry

📌 Summary Table of Class C Registration Steps

⏱ Estimated Timelines

💵 Cost Breakdown (Estimated)

✅ Final Tips

• Ensure all documents are in English or Arabic (Arabic is mandatory for IFU and labeling)

• Use a trusted and SFDA-experienced Authorized Representative

• Reference existing approvals (e.g., CE, FDA) to streamline the process

• Keep all certificates valid and up to date

• Monitor SFDA updates—regulatory changes can occur

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