Before applying for Class D medical device registration in Saudi Arabia, thorough preparation is crucial due to the stringent requirements SFDA imposes on high-risk devices. Proper preparation can significantly streamline the application process, reduce review times, and increase the likelihood of approval.

Here’s a detailed checklist of preparations you need to complete before submitting your application:

🛠️ Preparations Before Applying for Class D Medical Device Registration in Saudi Arabia

1. Confirm Device Classification

• Review SFDA’s classification rules to ensure your device is correctly classified as Class D.

• Prepare documentation justifying classification based on risk and intended use.

2. Appoint a Local Authorized Representative (LAR)

• If the manufacturer is outside Saudi Arabia, appoint a Saudi-based LAR.

• Ensure the LAR has:

  • Valid Saudi commercial registration

  • SFDA Establishment License (EL) or plans to obtain it

  • Capability to manage regulatory communications and compliance

3. Obtain Establishment Licenses (EL)

• Both manufacturer (if applicable) and LAR must obtain an Establishment License via SFDA’s GHAD platform.

• Gather required documents such as:

  • Commercial registration

  • ISO 13485 certificate

  • LAR appointment letter

• Submit and get EL approval before device registration.

4. Develop or Update Quality Management System (QMS)

• Ensure the manufacturer holds a valid ISO 13485:2016 certification from an SFDA-recognized body.

• QMS scope should cover the specific Class D device.

• Prepare QMS documents that demonstrate complaint handling, risk management, and recall processes.

5. Compile Complete Technical Documentation (Design Dossier)

• Prepare a full technical file including:

  • Device description and specifications

  • Risk management report (ISO 14971)

  • Verification and validation reports (bench, electrical, software)

  • Biocompatibility and sterilization validation (if applicable)

  • Clinical Evaluation Report (CER)

  • Labeling and Instructions for Use (IFU) in Arabic and English

  • Regulatory approvals from other jurisdictions (e.g., CE, FDA)

• Organize documentation clearly and in PDF format.

6. Prepare Clinical Evidence

• Collect or generate sufficient clinical data to support safety and performance claims.

• Develop a detailed Clinical Evaluation Report (CER) per SFDA guidelines.

• Ensure equivalence justification if relying on similar devices.

7. Ensure Compliance of Labeling and IFU

• Design labels and IFU that comply with SFDA bilingual requirements.

• Include all mandatory information such as:

  • Manufacturer and LAR details

  • Expiry date and batch numbers

  • Warnings and symbols per ISO 15223-1

• Translate and proofread Arabic text for accuracy.

8. Prepare Regulatory Documentation

• Gather:

  • CE certificates, FDA clearances, or other market approvals

  • Declaration of Conformity (DoC)

  • Certificate of Free Sale (CFS)

  • Market history and sales data if available

9. Register Accounts on SFDA Platforms

• Ensure both manufacturer and LAR have accounts on:

  • GHAD portal for Establishment License

  • MDNR portal for device registration

  • SABER portal for customs clearance (post-registration)

• Ensure proper user roles and permissions for submissions.

10. Plan for Fees Payment

• Prepare budget for registration fees, which are substantial for Class D devices.

• Fees include Establishment License application, device registration, and possible testing.

11. Internal Review and Pre-submission Audit

• Conduct an internal audit of the entire registration package.

• Optionally, engage a regulatory consultant to pre-review your dossier for gaps.

• Prepare to address potential SFDA queries efficiently.

📌 Summary Checklist Before Application

Would you like help with a detailed document checklist, templates for Clinical Evaluation Report or Risk Management, or guidance on navigating the SFDA portals before submission?