The time frame for applying for Class C medical device registration with the Saudi Food and Drug Authority (SFDA) can vary depending on several factors such as the complexity of the device, the completeness of the application, and the need for additional information or inspection. However, generally, the entire registration process for a Class C medical device can take approximately 3 to 6 months from the submission of the application to the final approval, provided that all documentation is complete and compliant with SFDA regulations.

Stages of the Review Process for Class C Medical Device Registration

The registration process for Class C medical devices with the SFDA is divided into several stages. Each stage may take varying amounts of time based on factors such as device complexity and completeness of the submission.

1. Application Submission (1-2 weeks)

• Action: Submit the medical device registration application via the SFDA’s eServices portal.
• Required Documentation: Include all necessary documents such as:
  • Device description and classification.
  • Risk management plan (ISO 14971).
  • Biocompatibility testing results (if applicable).
  • Clinical data (if applicable).
  • Product labeling (in Arabic and English).
  • GMP certificate for the manufacturing site (if applicable).
• Timeframe: Typically, this stage takes 1-2 weeks, as it involves filling out the online application form and uploading documents. However, the time may vary depending on the preparation of the documentation.

2. Initial SFDA Review (1-2 months)

• Action: Once the application is submitted, the SFDA will begin the initial review of the submitted documents.
  • Document review: SFDA reviews the application and all supporting documentation to ensure completeness and compliance with Saudi regulations.
  • Risk management and clinical data review: For Class C devices, SFDA assesses the risk management plan and clinical data to ensure safety and effectiveness.
  • Manufacturer’s GMP compliance: If the device is manufactured outside Saudi Arabia, the SFDA will check the manufacturer’s GMP certification to ensure compliance with international standards.
• Timeframe: This stage typically takes 1 to 2 months. However, this may be extended if the device is complex or if additional documentation is required.

3. Request for Additional Information or Clarifications (2-4 weeks, if applicable)

• Action: If the SFDA requires additional information or clarification regarding the submitted documents, they will request it from the applicant.
  • Follow-up: The manufacturer or authorized representative must respond to the SFDA’s requests for further details or revisions.
  • Revisions: This may include submitting more clinical trial data, updating risk assessments, or modifying the labeling to meet SFDA requirements.
• Timeframe: The time required for this stage can vary depending on how quickly the manufacturer provides the requested information. On average, it can take 2 to 4 weeks.

4. Manufacturing Facility Inspection (if applicable) (1-3 months)

• Action: For foreign manufacturers, the SFDA may conduct an inspection of the manufacturing facility to verify Good Manufacturing Practices (GMP) compliance.
  • Inspection process: If the facility is located outside Saudi Arabia, the SFDA may send inspectors or require GMP certification from a recognized body. If the manufacturer is already certified by a regulatory agency like the US FDA or European Medicines Agency (EMA), this process may be expedited.
  • Timeframe: The facility inspection, if required, can take anywhere from 1 to 3 months depending on the location of the facility and the scheduling of the inspection.

5. Final SFDA Review and Approval (1-2 months)

• Action: After completing the initial review and any inspections, the SFDA will make the final decision.
  • Decision Making: The SFDA evaluates all the provided documents, risk management plans, clinical data, and inspection reports before issuing a decision.
  • Approval: If everything is in order, the SFDA will approve the registration and issue a registration certificate, which is valid for five years.
  • Rejection: If the device does not meet the regulatory requirements, the SFDA will issue a rejection with reasons for the decision, and the manufacturer may need to submit additional information or make necessary changes before reapplying.
• Timeframe: This final decision stage typically takes 1 to 2 months.

Total Timeframe Estimate

The entire process for Class C medical device registration with the SFDA can take anywhere from 3 to 6 months, depending on several factors:

• If additional information is required or if the application is incomplete, the timeline can be extended.
• For foreign manufacturers, the facility inspection process may add additional time, especially if the manufacturing facility is located in a country that requires more logistical coordination for inspection.
• If the SFDA has no issues with the documentation or manufacturing facility, the process can move quickly.

Factors That Affect the Timeline

1. Completeness of Documentation: Applications with all required documents in the correct format can be processed faster.
2. Complexity of the Device: Devices that involve more complicated clinical trials, higher risks, or more stringent standards (such as those that require extensive clinical data) may require longer review times.
3. GMP Compliance: If the manufacturing facility is not already GMP-certified by a recognized body, the inspection process will add time.
4. Request for Additional Information: If the SFDA needs additional information or clarification, the timeline will be extended based on how quickly the manufacturer can provide the required documentation.

Summary of Time Frame for Class C Medical Device Registration Process

1. Application Submission: 1-2 weeks.
2. Initial SFDA Review: 1-2 months.
3. Request for Additional Information: 2-4 weeks (if applicable).
4. Manufacturing Facility Inspection (if applicable): 1-3 months.
5. Final SFDA Review and Approval: 1-2 months.

In total, the process typically takes between 3 to 6 months, but it could be shorter or longer depending on various factors related to the device, documentation, and inspection requirements.

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