The process for D-class medical device SFDA registration in Saudi Arabia is rigorous due to the high-risk nature of these devices. The Saudi Food and Drug Authority (SFDA) regulates medical devices to ensure their safety, efficacy, and quality. Below is a comprehensive overview of the steps involved in registering a D-class medical device with the SFDA.

Step 1: Determine Classification and Eligibility

• Device Classification: D-class devices are classified as high-risk devices, typically involving life-sustaining or life-supporting devices, implants, or devices that require a high level of control due to their potential risks. Ensure that your device qualifies as D-class based on SFDA's classification guidelines.
• Eligibility to Register: Only authorized representatives or manufacturers that meet the requirements set by SFDA can apply for registration. If you're an overseas manufacturer, you need to appoint a local authorized representative in Saudi Arabia.

Step 2: Prepare for Registration

• Regulatory Requirements: Before starting the application, ensure that the device meets SFDA’s technical, safety, and performance standards, such as:
  • ISO 13485 (Quality Management System certification).
  • Compliance with IEC 60601 (for electrical medical devices) or other applicable standards.
  • Clinical data supporting the device’s safety and performance.
• Technical Documentation: Prepare all necessary technical documentation, including:
  • Risk Management File (ISO 14971).
  • Clinical Evaluation Report (CER).
  • Product Specifications.
  • Device Labeling and Instructions for Use (IFU) in Arabic and English.
  • Manufacturing Site Certification.
  • Compliance with ISO 13485.
  • Biocompatibility and Sterilization Data (if applicable).
• Authorized Representative Appointment: If you are not based in Saudi Arabia, you must appoint a local authorized representative who will handle all regulatory matters with the SFDA.

Step 3: Register the Device in the SFDA’s MDMA System

• Create an Account: Log in to the Saudi Food and Drug Authority’s (SFDA) Medical Device Marketing Authorization (MDMA) system via the Saudi Unified Electronic System (SUES) platform. This platform allows you to submit your registration application online.
• Submit Device Information: Provide detailed information about the device, including:
  • Device name, type, and classification.
  • Manufacturer details and production sites.
  • Intended use and indications.
  • Labeling and IFU.
  • Clinical data, risk analysis, and safety reports.

Step 4: Submission of Documentation and Payment of Fees

• Documentation: Upload the required documents to the SFDA system. These may include:
  • Technical File (including risk management, design, and performance data).
  • Clinical Evaluation Report (with supporting clinical data or study results).
  • Conformity Assessment Report (showing the device complies with applicable standards like ISO 13485 or IEC standards).
  • Device Labeling and IFU (translated into Arabic).
  • Registration Fees: Pay the applicable registration fees through the SFDA’s payment portal. Fees may vary based on the device type and complexity of the registration process.

Step 5: SFDA Review and Evaluation

• Review Process: Once the documents are submitted, the SFDA will review the application to ensure it meets all regulatory requirements. This can involve:
  • Assessment of technical documentation (device safety, performance, and risk management).
  • Review of clinical evidence (clinical trials, performance studies).
  • Labeling and IFU review (to ensure they meet SFDA requirements, including translation into Arabic).
  • Conformity assessment (review of compliance with relevant standards like ISO 13485, ISO 14971, and IEC 60601).
• Further Documentation: If SFDA identifies any gaps or issues in the documentation, they will request additional information or clarification. You must respond to these queries promptly.
• Inspection: SFDA may also conduct an inspection of the manufacturing facility, especially if the device is being imported from abroad.

Step 6: Approval and Registration

• Issuance of Registration Certificate: If the SFDA is satisfied with the application and documentation, they will issue an official registration certificate for the D-class medical device. This means the device is now authorized to be marketed and sold in Saudi Arabia.
  • Validity: Typically, the registration is valid for one year.
  • The registration certificate must be renewed annually, which requires submitting updated documentation (e.g., post-market surveillance data, safety reports, and other regulatory updates).

Step 7: Post-Market Surveillance and Ongoing Compliance

• Post-Market Surveillance (PMS): After registration, the manufacturer is required to monitor the device’s safety and performance in the market. This involves:
  • Adverse event reporting: Any adverse reactions, device failures, or safety concerns must be reported to SFDA within a defined period (usually within 15 days).
  • Periodic Safety Update Reports (PSUR): Manufacturers may need to submit PSURs to update SFDA on the device’s safety and effectiveness.
  • Corrective Actions: If safety concerns are identified, manufacturers may need to initiate corrective actions, including recalls, labeling updates, or changes in manufacturing processes.
• Renewal: The D-class device registration must be renewed annually. The manufacturer must submit updated documentation (e.g., clinical evaluation, post-market surveillance reports, updated IFU) before the expiry date to maintain the registration status.

Step 8: Market and Distribution in Saudi Arabia

• Importation Requirements: If the device is imported, it must go through customs, and the local distributor must hold the appropriate licenses and approvals to distribute medical devices in Saudi Arabia.
• Authorized Representatives: If you are an overseas manufacturer, the authorized representative in Saudi Arabia will be responsible for ensuring ongoing compliance, including maintaining the registration and handling any regulatory communications from SFDA.

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