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What is the registration timeline for Class D medical devices in Saudi Arabia?
Release time：2025-07-09 16:59:51 The author: source:
The registration timeline for Class D medical devices in Saudi Arabia is generally longer than for lower-risk devices due to the high-risk nature and the thorough review process mandated by the Saudi Food and Drug Authority (SFDA).

The registration timeline for Class D medical devices in Saudi Arabia is generally longer than for lower-risk devices due to the high-risk nature and the thorough review process mandated by the Saudi Food and Drug Authority (SFDA).

Here’s a detailed breakdown of the typical timeline you can expect for Class D medical device registration:

⏳ Typical Registration Timeline for Class D Medical Devices

Registration PhaseEstimated DurationDetails
1. Preparation Phase1 – 3 monthsCompiling technical documentation, clinical evaluation, QMS certificates, translations, and appointing Local Authorized Representative (LAR).
2. Establishment License (EL) Application & Approval2 – 4 weeksApplication for EL via GHAD portal for manufacturer and LAR; necessary before device submission.
3. Submission via MDNR Portal1 weekUploading files, completing application forms, paying fees.
4. Administrative Review by SFDA2 – 4 weeksInitial screening for completeness and correct classification; requests for missing info if needed.
5. Technical & Clinical Evaluation by SFDA3 – 6 monthsDetailed assessment of technical dossier, clinical data, labeling, and risk management documents. This is the longest phase.
6. Additional Requests / Clarifications1 – 2 months (variable)SFDA may request extra information, tests, or documentation; the clock pauses until responses are provided.
7. Possible On-site Audit or Inspection1 – 2 months (if triggered)SFDA may audit manufacturing site or quality system, especially for high-risk devices.
8. Final Decision & Issuance of MDMA1 – 2 weeksOnce all requirements are met, SFDA issues the Medical Device Marketing Authorization (MDMA) certificate.

🔑 Total Estimated Time: 6 to 12 months

  • Most Class D registrations take about 6 to 12 months from initial submission to final approval.

  • Delays may occur due to:

    • Incomplete documentation

    • Slow responses to SFDA queries

    • Need for additional testing or clinical data

    • Scheduling or results of SFDA audits

⚡ Tips to Shorten Timeline

  • Prepare a complete and high-quality dossier upfront — especially strong clinical evaluation reports and risk management.

  • Ensure Arabic translations are accurate and ready before submission.

  • Respond promptly to SFDA queries to avoid hold-ups.

  • Work with an experienced Local Authorized Representative (LAR) familiar with SFDA processes.

  • Leverage prior approvals (CE, FDA) to support dossier strength.

Summary Table of Estimated Timeline

StageTimeframe
Document Preparation1 – 3 months
Establishment License (EL)2 – 4 weeks
Submission & Admin Review3 – 5 weeks
Technical & Clinical Review3 – 6 months
Queries & Responses1 – 2 months
Possible On-site Audit1 – 2 months
Final Approval & MDMA Issuance1 – 2 weeks

If you want, I can provide a detailed project timeline template or help you prepare a dossier checklist to streamline your Class D registration process in Saudi Arabia!

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