The D-class medical device SFDA registration application in Saudi Arabia can take several months due to the high-risk nature of the device and the detailed review process required by the Saudi Food and Drug Authority (SFDA). The total time for the application process depends on several factors, including the completeness of the application, the complexity of the device, and the SFDA's review capacity. On average, the entire process can take 3 to 6 months from submission to approval.

1. Overview of the Timeline

• Pre-registration preparation: 1-2 months (gathering and preparing documentation).
• Application submission: 1-2 weeks (electronic submission via the MDMA system).
• SFDA Review: 3-6 months (depending on the complexity of the device and completeness of the application).
• Approval and Registration Certificate: 1-2 weeks after successful review.
• Total time: 3 to 6 months (depending on the complexity and completeness of the application).

2. Steps Involved in the SFDA Review Process for D-Class Devices

The SFDA's review process for D-class medical devices involves a detailed and thorough evaluation to ensure that the device meets all regulatory requirements for safety, performance, and compliance. Here's a breakdown of the steps involved:

Step 1: Application Submission

• Online Submission: The manufacturer or authorized representative submits the registration application via the Saudi Unified Electronic System (SUES) or MDMA system.
• Required Documents: The application includes various documents, such as:
  • Technical file (including risk management documentation, performance data, and compliance with relevant standards).
  • Clinical evaluation reports (showing evidence of the device’s safety and efficacy).
  • Risk management reports (ISO 14971).
  • Compliance with ISO 13485 (quality management system) and other applicable standards (e.g., IEC 60601 for electrical devices).
  • Device labeling and Instructions for Use (IFU) in both Arabic and English.

Estimated Time for Submission: 1-2 weeks to complete and submit the online application and documents.

Step 2: Administrative Review

• Initial Review: The SFDA will first conduct an administrative review of the submission to ensure that all required documents are included and that they meet the necessary format and standards.
• Completeness Check: SFDA will check that all forms are correctly filled out, the payment of fees has been made, and all documentation (e.g., clinical reports, technical file) is included.
• Compliance Check: Ensures that the device complies with the relevant Saudi regulations and international standards such as ISO, IEC, and others applicable to the device type.

Estimated Time: 1-2 weeks.

Step 3: Technical Review

• Evaluation of Safety and Performance: The SFDA reviews the technical documentation, including:
  • Clinical Evidence: Detailed review of clinical trials or studies to demonstrate the device’s safety and effectiveness.
  • Risk Management File: Evaluation of the manufacturer’s risk management process and its compliance with ISO 14971. This includes an assessment of potential risks associated with the device and the steps taken to mitigate them.
  • Device Performance: Assessment of the device’s performance data, including preclinical and clinical data, as well as conformity assessments based on international standards like IEC 60601 (electrical medical devices), ISO 13485, and ISO 14971 (risk management).
  • Compliance with Standards: Verification that the device meets the required technical standards (e.g., IEC standards, ISO 13485, ISO 14971, biocompatibility testing, sterilization validation, etc.).

Estimated Time: 6-8 weeks (depending on the complexity of the device and documentation).

Step 4: Labeling and Instructions for Use (IFU) Review

• Evaluation of Labeling: SFDA reviews the device labeling to ensure it includes all required information, such as:
  • Manufacturer details, device name, intended use, and indications for use.
  • Warnings, contraindications, and safety precautions.
  • Product serial numbers, lot numbers, or batch numbers (if applicable).
  • Expiration dates (for applicable devices).
  • Instructions for Use (IFU): The IFU must be clearly written and meet the SFDA’s requirements. It must also be translated into Arabic.

Estimated Time: 1-2 weeks.

Step 5: Post-Market Surveillance and Vigilance Plan Review

• Evaluation of Post-Market Plan: SFDA checks whether the manufacturer has a post-market surveillance (PMS) plan in place. This plan should outline how the manufacturer will monitor the device’s safety and performance once it’s in the market.
• Adverse Event Reporting: The manufacturer must ensure they have procedures for reporting any adverse events, device failures, or issues related to the device’s use.
• Renewal and Compliance with SFDA’s Ongoing Requirements: SFDA will also evaluate whether the manufacturer is ready to comply with annual renewals and periodic safety update reports (PSUR).

Estimated Time: 1-2 weeks.

Step 6: Decision and Approval

• Final Decision: After reviewing all the documentation, the SFDA will make a decision:
  • Approval: If the device meets all SFDA regulatory requirements, the registration will be approved.
  • Rejection or Request for Additional Information: If there are any gaps in the application or concerns about the device's safety or efficacy, the SFDA may request additional documentation or clarification.

Estimated Time: 1-2 weeks.

Step 7: Issuance of Registration Certificate

• Notification: Once the SFDA has completed its review and approved the application, they will issue a registration certificate for the D-class medical device.
  • The registration certificate is typically valid for one year.
  • The manufacturer or authorized representative will be notified of the approval and issued a certificate.

Estimated Time: 1-2 weeks after approval.

Step 8: Post-Market Surveillance and Reporting

After the device is approved, manufacturers are required to comply with post-market surveillance and safety reporting requirements. This includes submitting periodic safety update reports (PSURs) and adverse event reports to the SFDA.

Total Estimated Time for D-Class Medical Device SFDA Registration

• Overall Time: The entire process, from submitting the application to receiving approval, typically takes between 3 to 6 months.
  • The length of time depends on the complexity of the device, the completeness of the application, and how quickly the manufacturer responds to any requests for additional information from SFDA.

Factors That May Affect the Review Timeline

• Completeness of Documentation: Incomplete or unclear documentation can delay the review process. Ensure that all required documents are submitted in the correct format.
• Complexity of the Device: High-risk D-class devices may require more detailed review, clinical studies, and performance data, which can extend the review timeline.
• SFDA Workload: SFDA's processing time may also vary based on their workload and the volume of applications they are handling at the time.
• Changes or Updates: Any changes to the regulations, standards, or required documentation after the initial submission could result in delays.

By understanding the steps involved in the review process and being prepared with comprehensive documentation, manufacturers can help ensure a smooth and timely SFDA registration process for their D-class medical device.

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