The procedures for applying and registering Class D medical devices in Saudi Arabia follow a defined regulatory pathway set by the Saudi Food and Drug Authority (SFDA) to ensure the safety, quality, and efficacy of high-risk devices before they enter the Saudi market.

Here is a detailed outline of the key procedural steps:

Step 1: Confirm Device Classification

• Determine that the medical device falls under Class D as per SFDA classification guidelines (highest risk).

• Classification dictates the scope of documentation and review rigor.

Step 2: Establish Legal Entities and Licenses

• Local Authorized Representative (LAR):
  If the manufacturer is outside Saudi Arabia, appoint an LAR registered in Saudi Arabia with a valid Establishment License (EL).

• Establishment License (EL):
  Both the manufacturer (if Saudi-based) and LAR must hold valid ELs, issued via the GHAD portal.

Step 3: Prepare Technical Documentation

• Compile a comprehensive technical dossier including:

  • Device description, design, and specifications

  • Risk management file (ISO 14971)

  • Verification and validation reports (including clinical data)

  • Clinical Evaluation Report (CER)

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

  • Certificates of conformity or approvals from recognized regulatory bodies (e.g., CE, FDA)

  • Quality management system certification (ISO 13485)

Step 4: Register on SFDA Portals

• GHAD portal: For Establishment License applications and renewals.

• MDNR (Medical Devices National Registry) portal: For device registration application.

• SABER platform: For import clearance after registration approval.

Step 5: Submit Registration Application via MDNR Portal

• The LAR submits the full registration application electronically, attaching all required documents.

• Pay applicable fees as per SFDA fee schedule.

Step 6: SFDA Review Process

• Administrative review: Checking completeness and compliance of submitted documents.

• Technical and clinical review: Detailed assessment of device safety, efficacy, and quality.

• SFDA may request additional information or clarification during this stage.

Step 7: Respond to SFDA Queries

• Provide clear, timely responses to any SFDA requests to avoid delays.

• Submit any supplementary data or revised documentation as needed.

Step 8: Possible On-site Inspection

• SFDA may conduct audits at manufacturing or LAR facilities, focusing on compliance with ISO 13485 and good manufacturing practices.

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

• Upon successful completion of reviews and audits, SFDA issues the MDMA certificate.

• This certificate allows importation, distribution, and marketing of the Class D medical device in Saudi Arabia.

Step 10: Post-Approval Obligations

• Maintain post-market surveillance.

• Report adverse events and safety issues.

• Renew registration before expiry.

• Keep Establishment Licenses current.

Summary Table of Procedures

If you want, I can provide detailed templates for your registration dossier, or guide you through the MDNR submission process for your Class D device in Saudi Arabia.

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