The registration process for Class D medical devices in Saudi Arabia is managed by the Saudi Food and Drug Authority (SFDA) and involves several key steps to ensure the device’s safety, efficacy, and compliance with local regulations before marketing approval is granted.

Here is a detailed step-by-step guide for the Class D medical device registration process in Saudi Arabia:

Step 1: Confirm Device Classification

• Verify that your device qualifies as Class D (highest risk) according to SFDA classification rules.

• Proper classification is critical because it dictates the depth of review and documentation required.

Step 2: Appoint a Local Authorized Representative (LAR)

• For foreign manufacturers, appoint a Saudi-based Local Authorized Representative.

• The LAR must hold a valid Establishment License (EL) issued by SFDA.

Step 3: Obtain Establishment License (EL)

• Both the manufacturer (if located in Saudi Arabia) and the LAR must obtain an Establishment License via the GHAD platform.

• Submit required company documents (commercial registration, ISO 13485 certificate, etc.).

• EL approval is a prerequisite for device registration.

Step 4: Prepare Technical Documentation (Design Dossier)

• Compile a comprehensive dossier including:

  • Device description, specifications, and intended use

  • Risk management report (ISO 14971)

  • Verification and validation data (electrical, mechanical, clinical)

  • Clinical Evaluation Report (CER)

  • Biocompatibility and sterilization information (if applicable)

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

  • Copies of international regulatory approvals (CE, FDA, etc.)

• Organize files per SFDA guidelines for electronic submission.

Step 5: Register and Submit Application via MDNR Portal

• The LAR submits the registration application through the Medical Devices National Registry (MDNR) portal.

• Upload all required documents and pay the registration fees.

• Confirm all information is accurate and complete to avoid delays.

Step 6: Administrative and Technical Review by SFDA

• SFDA performs:

  • Administrative review for completeness and classification accuracy.

  • Technical review assessing safety, performance, clinical data, and labeling.

• SFDA may request additional information or clarifications.

Step 7: Respond to SFDA Queries

• Provide timely and thorough responses to any SFDA questions or requests for additional documents.

• Delays in response may prolong the registration timeline.

Step 8: Possible SFDA On-site Inspection or Audit

• SFDA may conduct an audit of the manufacturing site or the LAR’s premises, particularly for high-risk devices.

• Prepare your quality management system and records accordingly.

Step 9: Approval and Issuance of Medical Device Marketing Authorization (MDMA)

• Upon successful review, SFDA issues the MDMA certificate.

• The certificate authorizes marketing and import of the Class D medical device in Saudi Arabia.

Step 10: Post-Market Obligations

• After registration, comply with post-market surveillance, adverse event reporting, and renewal requirements.

• Maintain valid Establishment Licenses and keep SFDA informed of any significant changes.

Summary Table of Steps

If you want, I can provide a checklist of required documents or help you with detailed instructions on how to use the GHAD and MDNR platforms for your Class D medical device registration in Saudi Arabia.

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