The registration process for a B-class medical device with the Saudi Food and Drug Authority (SFDA) typically takes approximately 4-6 months to complete, depending on various factors such as the complexity of the device, the completeness of the application, and whether additional testing or inspections are required. Below is a more detailed breakdown of the review process and estimated timeline for each step.

Steps in the Review Process for B-Class Medical Device Registration

1. Submission of Application (Step 1)

• Estimated Time: 1-2 weeks (depending on preparation time)
• Action: You will submit your registration application via the SFDA online portal (MDA or SDAIA platform), along with all the required documents, such as:
  • Device details and classification
  • Manufacturer's information
  • Quality Management System (QMS) compliance (e.g., ISO 13485)
  • Clinical data and safety information
  • Device labeling and Instructions for Use (IFU)
  • Risk management documentation
• What to Pay Attention To: Ensure all documentation is complete and accurate. Missing or incorrect information can delay the process.

2. Initial Review of Application (Step 2)

• Estimated Time: 2-4 weeks
• Action: SFDA will conduct a preliminary review of the submitted documents to ensure that they meet the basic regulatory requirements.
  • The SFDA checks the classification of the device (B-class), verifies manufacturer information, and assesses whether the device falls under the scope of SFDA’s medical device regulations.
  • This review includes checking whether ISO 13485 certification is provided and whether the device’s intended use aligns with its classification.
• What to Pay Attention To: Ensure that all documents are well-organized and meet SFDA requirements to avoid delays in the initial review phase.

3. Detailed Evaluation of Device Documentation (Step 3)

• Estimated Time: 4-6 weeks
• Action: During this stage, SFDA evaluates the more detailed aspects of the application:
  • Clinical Data Review: SFDA will assess the clinical data submitted for the device. This could include clinical trials, post-market surveillance data, or other performance data that supports the device's safety and effectiveness.
  • Risk Management Review: SFDA evaluates the device's risk management file to ensure that risks are properly identified and mitigated, in line with ISO 14971 standards.
  • Testing Data: If necessary, SFDA will review any test reports or safety certifications (e.g., biocompatibility, electrical safety, etc.).
  • Labeling Compliance: The labels and Instructions for Use (IFU) are reviewed for compliance with SFDA’s requirements for language (Arabic and English), content, and format.
  • Manufacturing Compliance: SFDA may review documentation related to the manufacturing process and request evidence of compliance with Good Manufacturing Practices (GMP) or relevant ISO standards.
• What to Pay Attention To: Ensure clinical and safety data is clearly presented and supported by valid sources. The device labels and IFU must be compliant with SFDA regulations.

4. Additional Testing or Inspection (Step 4) (if applicable)

• Estimated Time: 2-6 weeks (if required)
• Action: Depending on the nature of the device, SFDA may request additional product testing or may require an inspection of the manufacturing facility to confirm compliance with GMP.
  • If SFDA requires testing, you will need to arrange for testing through SFDA-approved laboratories. The testing could include assessments like electrical safety, biocompatibility, sterility, and more.
  • If the device is manufactured outside of Saudi Arabia, SFDA may schedule an inspection of the manufacturing site to ensure compliance with international manufacturing standards.
• What to Pay Attention To: Be prepared to provide additional test reports or facilitate inspections promptly to avoid delays.

5. Final Review and Decision (Step 5)

• Estimated Time: 1-2 weeks
• Action: Once all the necessary documents have been reviewed, SFDA will issue a final decision on the registration of the device.
  • Approval: If the device meets all regulatory requirements, SFDA will approve the application and issue a Certificate of Registration.
  • Request for Additional Information: If the application is incomplete or requires further clarification, SFDA may request additional information or documentation. This could delay the process.
  • Rejection: If the device does not meet the required regulatory standards, SFDA may reject the application. In such cases, you will need to resolve the issues and reapply.

6. Issuance of Registration Certificate (Step 6)

• Estimated Time: 1-2 weeks
• Action: After the approval, SFDA will issue the Certificate of Registration and assign a registration number. This number will be required for marketing and distribution in Saudi Arabia.
  • The registration certificate is valid for one year, and you will need to renew it annually by submitting updated documentation and paying applicable fees.
• What to Pay Attention To: Ensure that the certificate is accurately issued, and the registration number is displayed on the device’s packaging and labeling.

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