The D-class medical device registration process with the Saudi Food and Drug Authority (SFDA) typically takes approximately 1-3 months from submission to approval. However, the exact duration can vary depending on the complexity of the device, the completeness of the application, and whether any additional information or clarification is required by the SFDA.

Here is a detailed breakdown of the steps involved in the review process and factors that influence the timeline:

1. Application Submission (1-3 Days)

• Step Description: The process begins by submitting the registration application via the Saudi Drug Registration System (SDRS). This includes uploading all required documentation, such as device descriptions, quality management system (QMS) certifications, risk management files, and labeling information.
• Timeframe: Typically takes 1-3 days to gather and submit all the required documents. The length of this step depends on how prepared the manufacturer is and how quickly the local authorized representative (LAR) can submit the application.

2. SFDA Acknowledgment of Submission (1-2 Weeks)

• Step Description: After submission, the SFDA will acknowledge receipt of the application and initiate an initial review to ensure all required documents are in place. If the application is incomplete or if additional information is needed, the SFDA will notify the applicant (through the LAR).
• Timeframe: This initial acknowledgment usually takes about 1-2 weeks. If the application is incomplete, this can extend by another week or two depending on how long it takes the applicant to provide the necessary information.

3. SFDA Technical Review (3-4 Weeks)

• Step Description: The SFDA performs a detailed technical evaluation of the application. This includes reviewing the following:
  • Device classification and intended use
  • Documentation compliance (e.g., ISO certifications, risk management, clinical data if needed)
  • Labeling, packaging, and Instructions for Use (IFU) in both Arabic and English
  • Quality management system (QMS) documentation (ISO 13485 certification or equivalent)
• Timeframe: The technical review typically takes about 3-4 weeks, but this can vary based on the complexity of the device and the completeness of the application. D-class devices, being lower risk, generally undergo a more straightforward review compared to higher-risk devices.

4. SFDA Decision (1-2 Weeks)

• Step Description: Based on the technical review, the SFDA will make a decision:
  • Approval: If the device complies with all regulatory requirements, the SFDA will issue a registration approval.
  • Request for Additional Information: If the SFDA finds issues with the application (e.g., missing documents, unclear labeling, or non-compliance with quality standards), they will request additional information or clarification.
  • Rejection: If the application does not meet the necessary standards, it may be rejected.
• Timeframe: The decision-making process usually takes about 1-2 weeks after the completion of the technical review.

5. Issuance of Registration Certificate (1 Week)

• Step Description: If the device is approved, the SFDA will issue a registration certificate. This certificate allows the device to be legally marketed and sold in Saudi Arabia.
• Timeframe: The issuance of the registration certificate typically takes about 1 week after the approval decision.

Total Time for D-Class Medical Device Registration

• Total Estimated Time: The entire process typically takes between 1 to 3 months, with the variation largely depending on the completeness of the initial application, whether additional information is needed, and the overall complexity of the device.

Steps in the SFDA Review Process

The review process itself involves several key steps, each designed to assess different aspects of the medical device to ensure its safety, effectiveness, and compliance with Saudi regulations:

1. Document Completeness Check:

   • The SFDA checks whether the application is complete. This includes ensuring all necessary forms, certifications (e.g., ISO 13485), risk assessments, clinical data (if applicable), and labeling materials are included.
   • If documents are missing or incomplete, the SFDA will return the application for revision, which can extend the timeline.

2. Technical Review:

   • The SFDA conducts a detailed review of the technical documentation to ensure the device complies with Saudi regulations and meets international safety and quality standards. This includes:
     • Risk management documentation (based on ISO 14971)
     • Quality management system certification (e.g., ISO 13485)
     • Clinical data (if applicable)
     • Performance and safety testing results (depending on the device)
   • Devices that comply with the classification for D-class (low risk) may undergo a more straightforward review than higher-risk devices.

3. Labeling Review:

   • The SFDA verifies that the device’s labeling (including packaging and Instructions for Use) complies with Saudi requirements. This includes ensuring the labeling is in both Arabic and English and follows SFDA guidelines for medical devices.
   • Any discrepancies or missing information in the labeling may cause delays.

4. Risk and Benefit Assessment:

   • The SFDA assesses the risk and benefit profile of the device based on the provided risk management documentation. For D-class devices, this will typically involve a simple evaluation of the device’s intended use and risk to users.
   • Low-risk devices generally require less detailed clinical evidence, but this will depend on the specific device type.

5. Post-Market Surveillance and Safety:

   • The SFDA may review the applicant's ability to comply with post-market surveillance (PMS) requirements, including reporting adverse events, conducting recalls if necessary, and ensuring ongoing safety monitoring.
   • D-class devices will generally have fewer post-market obligations than higher-risk devices, but it is still essential to provide evidence of compliance.

6. Final Approval and Registration Issuance:

   • After the review, the SFDA makes a final decision based on the compliance of the application with Saudi medical device regulations.
   • If approved, the SFDA will issue a registration certificate, which allows the device to be marketed in Saudi Arabia.
   • If additional information is required, the applicant will be asked to submit it. If the application is rejected, the applicant can address the issues and reapply.

Factors That Can Influence the Timeline:

• Completeness of the Application: Missing or incomplete documentation can delay the process, as the SFDA will need to request additional information or clarification.
• Device Complexity: While D-class devices are low-risk, more complex devices may require additional scrutiny during the review process.
• SFDA Workload: The review time may vary depending on the number of applications the SFDA is processing at a given time.
• External Factors: If the SFDA requires additional consultations, inspections, or if any issues arise with the device (e.g., safety concerns), the process may be delayed.

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