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How long does it take to apply for Class D medical device registration in Saudi Arabia, and what are the review procedures?
Release time：2025-07-09 17:07:35 The author: source:
The timeline to apply and obtain approval for Class D medical device registration in Saudi Arabia varies but typically takes 6 to 12 months due to the complexity and high risk associated with these devices.

The timeline to apply and obtain approval for Class D medical device registration in Saudi Arabia varies but typically takes 6 to 12 months due to the complexity and high risk associated with these devices. Below is a detailed breakdown of the application duration and the review procedures involved:

⏳ Typical Timeline for Class D Medical Device Registration

PhaseEstimated Duration
Preparation of Dossier & Documents1 to 3 months
Establishment License (EL) Approval2 to 4 weeks
Submission of Registration Application1 week
Administrative Review by SFDA2 to 4 weeks
Technical & Clinical Review by SFDA3 to 6 months
Queries and Additional Information1 to 2 months (variable)
Possible On-site Audit/Inspection1 to 2 months (if applicable)
Final Approval and MDMA Issuance1 to 2 weeks

🔍 Review Procedures Explained

1. Administrative Review

  • SFDA checks for completeness and correctness of the submitted application.

  • Validates classification, required documents, fees payment.

  • May request missing or incomplete information at this stage.

2. Technical Review

  • Thorough evaluation of the technical documentation including:

    • Device description and specifications

    • Risk management and safety data

    • Clinical evaluation report (CER)

    • Verification and validation test results

    • Labeling and Instructions for Use (IFU)

  • Conducted by SFDA experts to verify compliance with local and international standards.

3. Clinical Review

  • Focus on clinical evidence supporting device safety and performance.

  • SFDA assesses if the clinical data is sufficient for Class D device risks.

  • May require additional clinical investigations or post-market data.

4. Queries and Clarifications

  • SFDA sends questions or requests for supplemental information.

  • Applicant/LAR must respond promptly to avoid delays.

5. Possible On-site Audit

  • SFDA may audit the manufacturer’s facility or LAR’s office.

  • Audits verify compliance with Quality Management Systems (ISO 13485), production processes, and documentation.

6. Final Decision

  • After satisfactory review and audit (if any), SFDA grants the Medical Device Marketing Authorization (MDMA).

  • Approval letter and certificate are issued via the MDNR portal.

⚠️ Factors Affecting Timeline

  • Completeness and quality of dossier at submission

  • Timeliness of applicant’s responses to SFDA queries

  • Scheduling and outcome of on-site inspections

  • Changes or updates to SFDA regulatory requirements

  • Complexity and novelty of the device

Summary Table of Timeline and Process

StepDurationNotes
Document Preparation1 – 3 monthsInternal to applicant
EL Approval2 – 4 weeksVia GHAD portal
Submission~1 weekMDNR portal
Administrative Review2 – 4 weeksCompleteness check
Technical & Clinical Review3 – 6 monthsDeep dossier evaluation
Query Responses1 – 2 monthsDepends on applicant speed
On-site Audit (if any)1 – 2 monthsMay be triggered for Class D
Final Approval1 – 2 weeksMDMA certificate issuance

If you want, I can help you prepare a detailed project timeline template or provide tips to streamline each stage of your Class D medical device registration in Saudi Arabia.

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Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn


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