Registering a Class C medical device in Saudi Arabia involves a structured process regulated by the Saudi Food and Drug Authority (SFDA). Class C devices represent moderate-to-high risk and therefore require a thorough regulatory assessment.

Below is a comprehensive guide covering the procedures, required documents, and key considerations for a successful registration.

✅ 1. Procedures for Class C Medical Device Registration in Saudi Arabia

🔹 Step 1: Confirm Device Classification

• Use SFDA’s Medical Device Classification Rules, aligned with IMDRF/GHTF guidelines.

• You may optionally submit a classification consultation to SFDA if uncertain.

• Class C typically includes:

  • Infusion pumps

  • Electrosurgical devices

  • X-ray diagnostic systems

  • Antimicrobial wound dressings

🔹 Step 2: Appoint a Saudi Authorized Representative (AR)

• Mandatory for foreign manufacturers.

• The AR must be registered with SFDA and hold a valid Establishment License (EL).

• The AR will:

  • Submit applications on your behalf

  • Handle post-market surveillance and incident reporting

  • Serve as the official liaison to SFDA

🔹 Step 3: Obtain Establishment License (EL)

• Required for both the foreign manufacturer and the Saudi AR.

• Applied through the GHAD system: https://ghad.sfda.gov.sa

• Valid for one year, renewable.

🔹 Step 4: Prepare Technical Documentation

• Prepare a complete technical file based on GHTF or IMDRF format.

• All documents must be translated into English; Arabic translation is required for labeling and instructions for use.

🔹 Step 5: Submit the MDMA Application

• Use the SFDA’s GHAD/MDMA system to submit the Medical Device Marketing Authorization (MDMA) application.

• Upload all required documents and pay the application fee.

• Abridged or full review route:

  • If the device is CE-marked or FDA-cleared, you may qualify for abridged review.

  • Otherwise, full review applies.

🔹 Step 6: SFDA Review and Evaluation

• Timeline: ~3–6 months

• Includes review of:

  • Technical file

  • Risk classification

  • Clinical evaluation

  • Labeling and safety documentation

🔹 Step 7: Receive the MDMA Certificate

• Once approved, SFDA issues a Medical Device Marketing Authorization Certificate.

• Validity: Typically 3 years

🔹 Step 8: Post-Market Compliance

• Implement post-market surveillance (PMS) and vigilance systems.

• Report serious incidents, recalls, or field safety corrective actions (FSCA).

• Renew MDMA certificate before expiry.

📑 2. Required Documents for Class C Device Registration

Here is a complete checklist of documents required by SFDA for a Class C medical device:

All documents should be submitted electronically through the GHAD system, in PDF format.

🎯 3. Key Considerations for Class C Registration

⚠️ Risk-Based Scrutiny

• SFDA treats Class C devices with higher scrutiny than Class A or B.

• Expect more detailed review of clinical evidence and risk files.

🌍 International Certifications Help

• CE marking, FDA 510(k), or TGA approvals may facilitate the abridged review path.

🗣 Arabic Language Compliance

• All labeling, packaging, and IFU must be fully translated into Arabic.

• Failure to provide compliant Arabic labeling can lead to delays or rejection.

👩‍💼 Authorized Representative Role

• Choose an AR with proven experience and active registration.

• The AR is legally responsible for compliance and reporting inside Saudi Arabia.

💰 Fees and Timelines

• Cost Range: SAR 20,000–40,000 (USD ~$5,300–10,700)

• Typical Timeframe: 5–8 months

🔁 Renewal and Vigilance

• MDMA certificate valid for 3 years

• Requires active vigilance system and incident reporting

• Renewal must be initiated before expiry

📌 Summary Table

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