To apply for Class D medical device registration in Saudi Arabia, you must follow the official process laid out by the Saudi Food and Drug Authority (SFDA). This involves multiple steps, including the appointment of a Local Authorized Representative (LAR), submission of documentation, and registration through designated online platforms.

Below is a comprehensive guide on how and where to apply for Class D medical device registration in Saudi Arabia:

📝 Part 1: How to Apply for Class D Medical Device Registration

✅ Step-by-Step Process

Step 1: Classify Your Medical Device

• Use SFDA’s classification rules to confirm that the device falls under Class D (high risk).

• Refer to SFDA’s “Guidance on Classification Rules for Medical Devices”.

Step 2: Appoint a Local Authorized Representative (LAR)

• If the manufacturer is not based in Saudi Arabia, they must appoint a Saudi-based LAR.

• The LAR acts as the official contact with SFDA and submits the application.

🔹 The LAR must be a licensed Saudi company and hold an Establishment License (EL).

Step 3: Obtain Establishment License (EL)

• Both the manufacturer and the LAR must obtain an EL through SFDA’s GHAD platform.

📌 Portal: https://ghad.sfda.gov.sa

Required documents:

• Commercial registration

• Quality system certificate (ISO 13485)

• Appointment letter

• LAR agreement

Step 4: Prepare the Technical and Regulatory Documents

You will need to compile a complete technical file including:

• Design dossier

• Clinical evaluation report (CER)

• Risk management file (ISO 14971)

• CE/FDA certificates

• ISO 13485 certificate

• Instructions for Use (bilingual)

• Device labeling (Arabic + English)

• Certificate of Free Sale

• Declaration of Conformity

🧩 All documents must be submitted in PDF, and Arabic translation is required for IFU and labeling.

Step 5: Register the Device on the MDNR Platform

Apply through the Medical Devices National Registry (MDNR).

📌 Portal: https://mdnr.sfda.gov.sa

• Create an account for your LAR or manufacturer

• Enter product details (GMDN, classification, model info)

• Upload all required documents

• Pay applicable Class D registration fee

• Submit for review

Step 6: SFDA Review and Clarification

• SFDA conducts:

  • Administrative review (format and completeness)

  • Technical assessment (performance, safety, testing)

  • Clinical evidence review

  • Labeling and IFU compliance check

• SFDA may raise queries or request additional information

⏳ Timeframe: 6 to 12 months, depending on complexity

Step 7: Receive the Medical Device Marketing Authorization (MDMA)

• If approved, SFDA issues an MDMA certificate

• This certificate must be renewed periodically (usually every 3–5 years)

• The MDMA is required for customs clearance and legal marketing in Saudi Arabia

Step 8: Import Device via SABER System

Once approved, register the product with the SABER platform to import it through Saudi Customs.

📌 Portal: https://saber.sa

🏢 Part 2: Where to Apply and Manage the Process

📌 Summary Table

✅ Tips for Success

• Ensure your documents are organized and complete before submission.

• Work with an experienced LAR or regulatory consultant familiar with SFDA procedures.

• Ensure all labels and IFU are Arabic and English compliant.

• Monitor the MDNR portal for feedback or clarification requests.

• Respond promptly to all SFDA queries to avoid delays.

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