To apply for D-class medical device SFDA registration in Saudi Arabia, the process involves several key steps. Here's a detailed breakdown of the application process:

Steps to Apply for D-Class Medical Device SFDA Registration

Step 1: Preliminary Preparations

Before you start the registration process, ensure the following:

1. Device Classification Verification:

   • Confirm that your device is classified as D-class (high-risk) according to SFDA’s classification rules. D-class devices typically include life-supporting, life-sustaining, or implantable devices, or those that pose a significant risk to patient safety.

2. Authorized Representative:

   • If you are an overseas manufacturer, you must appoint a local authorized representative (LAR) in Saudi Arabia. The LAR will manage the registration process and handle communication with SFDA on your behalf.

3. Compliance with International Standards:

   • Ensure your device complies with international regulatory standards, such as:
     • ISO 13485 (Quality Management System)
     • ISO 14971 (Risk Management)
     • IEC 60601 (for electrical medical devices, if applicable)
     • ISO 10993 (for biocompatibility)
     • Relevant clinical trial data and performance testing.

4. Documentation Preparation:

   • Technical Documentation: Prepare all necessary documents, including:
     • Risk management file (compliant with ISO 14971)
     • Clinical evaluation reports (CER)
     • Performance and safety data
     • Manufacturing site certification
     • Post-market surveillance plans
     • Device labeling and Instructions for Use (IFU) (in Arabic and English)
   • Clinical Data: Provide evidence of clinical safety and efficacy, especially for high-risk devices.

Step 2: Create Account on SFDA's Unified Electronic System (SUES)

1. Register for SFDA Account: Create an account on the Saudi Unified Electronic System (SUES) if you don’t already have one. This is the official platform used to submit medical device registration applications to SFDA.
2. Log in to the MDMA System: Once registered, log in to the Medical Device Marketing Authorization (MDMA) system on the SUES platform.

Step 3: Submit Application via MDMA System

1. Complete the Application Form:

   • Fill in the online application form with details of the device, including:
     • Device name and classification (D-class).
     • Manufacturer details (name, address, and contact info).
     • Authorized representative details (if applicable).
     • Intended use, indications for use, and contraindications.

2. Upload Required Documents:

   • Upload all required technical documents, including:
     • Risk management file
     • Clinical evaluation report
     • Conformity assessment
     • Performance testing results
     • Post-market surveillance plan
     • Device labeling (including in Arabic)
     • Instructions for Use (IFU) (in both Arabic and English)

3. Device Classification:

   • Confirm that the device is correctly classified as D-class in the application form.

4. Pay Registration Fees:

   • Pay the applicable registration fees for your D-class medical device. Payment can be made directly through the SUES/MDMA system.

Step 4: SFDA Review Process

1. Administrative Review:

   • SFDA will initially perform an administrative review to ensure all required forms and documents are correctly submitted and complete. This review typically takes 1-2 weeks.

2. Technical Review:

   • After the administrative review, SFDA will conduct a detailed technical evaluation of the application, which may involve:
     • Risk management (ISO 14971)
     • Clinical evidence (safety and efficacy data)
     • Conformity to international standards (e.g., IEC 60601 for electrical devices, ISO 13485)

3. Inspection (if applicable):

   • If necessary, SFDA may request an inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.

4. Response to Queries:

   • If SFDA requires additional information or clarification, you will be notified. Respond to any queries promptly to avoid delays in the review process.

Step 5: Approval and Registration Certificate

1. Decision Notification:

   • Once the SFDA completes its evaluation, they will provide a decision:
     • Approval: If the device meets all regulatory requirements, SFDA will approve the registration and issue a registration certificate.
     • Rejection: If the device does not meet SFDA requirements, you may need to provide additional information or make necessary changes.

2. Issuance of Registration Certificate:

   • The registration certificate is issued for the D-class device and is typically valid for one year.

3. Notification:

   • You will receive a notification once the registration is approved and the certificate is issued.

Step 6: Post-Market Surveillance and Ongoing Compliance

1. Post-Market Surveillance (PMS):

   • After registration, ensure that a post-market surveillance plan is in place. SFDA requires periodic reporting of any adverse events or safety issues.
   • Adverse Event Reporting: Report any adverse events within 15 days of becoming aware of them.

2. Periodic Safety Update Reports (PSUR):

   • Submit periodic safety update reports if required, to demonstrate that the device remains safe and effective for use.

3. Annual Renewal:

   • The D-class device registration must be renewed annually. You will need to submit updated documents (e.g., post-market surveillance data) and pay the renewal fee.

4. Compliance with SFDA Guidelines:

   • Continuously comply with SFDA’s regulations, including any updates or new requirements related to device safety, labeling, and reporting.

Summary of the Steps

1. Verify device classification as D-class.
2. Appoint a local authorized representative (if applicable).
3. Prepare required documentation (clinical, risk management, performance data, labeling).
4. Create an account on SFDA's SUES and MDMA system.
5. Complete the application form and upload required documents.
6. Pay registration fees.
7. Submit the application to SFDA for review.
8. Respond to any SFDA queries or requests for additional information.
9. Wait for SFDA approval and issuance of the registration certificate.
10. Comply with post-market surveillance and annual renewal requirements.

Timeline Overview

• Pre-registration preparations: 1-2 months.
• Application submission: 1-2 weeks.
• SFDA review: 3-6 months (depending on complexity and completeness).
• Approval and registration certificate issuance: 1-2 weeks.
• Post-market surveillance: Ongoing after registration.

By following these steps carefully, you can ensure a smooth process for applying for D-class medical device SFDA registration in Saudi Arabia.

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