Handling the D-class medical device SFDA registration in Saudi Arabia involves a structured and rigorous process due to the high-risk classification of these devices. Below is a step-by-step guide to help you navigate the registration process with the Saudi Food and Drug Authority (SFDA).

Step-by-Step Guide to Handling D-Class Medical Device SFDA Registration

1. Determine Device Classification

• D-Class Device: These devices are considered high-risk, and they are typically life-supporting, life-sustaining, or implantable devices, or those that pose a higher risk to patient safety and health.
• Device Classification: Ensure that your device qualifies as D-class based on SFDA’s classification rules. D-class devices require the most detailed documentation and compliance to be registered.

2. Pre-Registration Preparations

a. Appoint a Local Authorized Representative

• If you are not based in Saudi Arabia, you need to appoint a local authorized representative (LAR) in Saudi Arabia who will handle the registration and ongoing compliance with SFDA regulations.

b. Compliance with SFDA Regulations

• Ensure that your device meets the Saudi regulations, including standards such as:
  • ISO 13485 (Quality Management System).
  • ISO 14971 (Risk Management).
  • IEC 60601 (for electrical medical devices, if applicable).
  • Biocompatibility, Sterilization, and Performance data.

c. Prepare Technical Documentation

The Technical Documentation is critical to the registration process for D-class devices. Key documents include:

• Risk Management File (based on ISO 14971).
• Clinical Evaluation Report (CER) or Clinical Data (to demonstrate safety and effectiveness).
• Conformity Assessment (showing compliance with relevant standards).
• Performance Data and Test Reports.
• Manufacturing Site Certification (if applicable).
• Labeling and Instructions for Use (IFU) in both English and Arabic.
• Post-Market Surveillance (PMS) Plan.

3. Submit Application via SFDA’s MDMA System

a. Create an Account

• Create a profile on the Saudi Unified Electronic System (SUES) and log into the Medical Device Marketing Authorization (MDMA) system to start the registration process.

b. Complete the Application Form

• Complete the required application forms through the MDMA system, which will require detailed information about the device:
  • Device name, classification, and type.
  • Manufacturer details (name, address, and contact information).
  • Authorized representative details (if applicable).
  • Intended use and indications for use.

c. Upload Documentation

• Upload the prepared technical documentation including the risk management file, clinical evaluation report, labeling, and other required materials to the MDMA system.

d. Pay Registration Fees

• Pay the applicable registration fees for the D-class device through the SFDA’s online payment portal. The fees vary depending on the complexity of the device and the number of supporting documents required.

4. SFDA Review and Evaluation

a. Administrative Review

• Completeness Check: SFDA will first check that all required forms, documents, and fees have been submitted. This is an administrative review, and it typically takes 1-2 weeks.

b. Technical Evaluation

• Detailed Review: SFDA will evaluate the device’s safety, effectiveness, and compliance with international standards. They will review:
  • Clinical Evidence: The clinical data and studies supporting the device’s safety and performance.
  • Risk Management: Ensuring the device complies with ISO 14971 and has proper risk mitigation strategies.
  • Compliance with Standards: Assessing whether the device conforms to relevant international standards (ISO 13485, ISO 14971, IEC 60601, etc.).
• Inspection: If required, SFDA may conduct a facility inspection (for overseas manufacturers) to verify the manufacturing process and quality systems.

Estimated Time for Review: 3-6 months, depending on the complexity and completeness of the submission.

5. Response to Queries or Additional Information

• If the SFDA identifies any gaps or issues in the submission, they may request additional information or clarification. This could include:
  • Providing more detailed clinical data or studies.
  • Clarifying labeling information.
  • Updating risk management files or performance data.
• Be proactive: Respond promptly to these queries to avoid delays in the registration process.

6. Approval and Issuance of Registration Certificate

• If SFDA finds that your device meets all regulatory requirements, they will issue a Registration Certificate for the D-class medical device.
• The registration certificate will typically be valid for one year.

Estimated Time for Approval: 1-2 weeks after the final review.

7. Post-Market Surveillance and Ongoing Compliance

a. Post-Market Surveillance (PMS)

• After registration, you must have a system in place for monitoring the safety and performance of the device once it’s on the market. SFDA requires:
  • Adverse event reporting (within 15 days of becoming aware of an adverse event).
  • Periodic Safety Update Reports (PSUR): These may be required to be submitted on a regular basis.
  • Recall or Field Safety Corrective Action: If a device defect is identified, you may need to initiate corrective actions, including recalls.

b. Annual Renewal

• D-class medical devices must be renewed annually. This involves submitting updated documentation (e.g., post-market data, clinical updates) and paying renewal fees.

c. Continuous Compliance

• Ensure that the device continues to meet SFDA's ongoing regulatory requirements, including:
  • Compliance with SFDA’s standards and guidelines.
  • Reporting any device failures or adverse events.

8. Market and Distribution in Saudi Arabia

• Once approved, the device can be marketed in Saudi Arabia. The local distributor must be licensed by SFDA, and they will be responsible for ensuring that all importation and distribution practices comply with SFDA regulations.

• Authorized Representative Role: If you are a foreign manufacturer, your local authorized representative will be responsible for handling any regulatory communication and maintaining ongoing compliance with SFDA requirements.

Challenges to Consider

1. Document Quality and Completeness: The quality and thoroughness of the submitted documentation are critical. Incomplete or inaccurate documents may delay the approval process.
2. Clinical Data: High-risk devices (D-class) often require detailed clinical evidence to demonstrate safety and efficacy. Preparing clinical data early in the process is crucial.
3. SFDA’s Processing Time: The review process can be lengthy, especially for D-class devices. Plan for delays and ensure all requested information is provided promptly.
4. Post-Market Compliance: Ongoing compliance with SFDA regulations is critical. Adverse events, product complaints, and other issues must be reported promptly.

Summary of Steps

1. Determine device classification (D-class).
2. Appoint a local authorized representative (if applicable).
3. Prepare technical documentation (clinical data, risk management, labeling, etc.).
4. Submit application via SFDA’s MDMA system and pay registration fees.
5. SFDA review and evaluation (administrative and technical review, potential inspection).
6. Respond to any requests for additional information or clarification.
7. Receive registration approval and certificate.
8. Post-market surveillance and compliance (adverse event reporting, periodic updates).
9. Renew registration annually and maintain ongoing compliance.

Estimated Timeline

• Pre-registration preparation: 1-2 months.
• Application submission: 1-2 weeks.
• SFDA review: 3-6 months (depending on the complexity of the device).
• Approval and registration certificate issuance: 1-2 weeks after successful review.
• Total estimated time: 3 to 6 months.

By following this process and maintaining thorough and accurate documentation, you can successfully handle the D-class medical device SFDA registration in Saudi Arabia.

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