After submitting the application for B-class medical device registration with the Saudi Food and Drug Authority (SFDA), there are several important regulations and requirements that need to be followed to maintain compliance and ensure your device remains on the market. These regulations fall under post-market obligations, as well as ongoing compliance with SFDA's standards for medical devices.

Here's a comprehensive breakdown of the regulations and requirements to follow after applying for B-class medical device registration with SFDA:

1. Post-Market Surveillance (PMS)

1.1 Monitor Device Performance and Safety

• Continuous monitoring of the device’s performance is a key post-market requirement. You must collect data regarding any issues, malfunctions, or user complaints to ensure the device’s ongoing safety and efficacy.
• Implement a system for ongoing post-market surveillance (PMS) to track any adverse events, failures, or safety issues with the device.

1.2 Adverse Event Reporting

• If any adverse events or incidents occur, you must report them to SFDA in accordance with SFDA’s vigilance requirements.
  • Serious incidents (e.g., death or serious health deterioration) must be reported immediately (within 10 working days).
  • Non-serious incidents should be reported within 15 days.
• Field Safety Corrective Actions (FSCA), including device recalls or safety notices, must be reported if necessary.
• Develop a process for gathering and reporting any complaints or safety-related information from the market.

1.3 Periodic Safety Update Report (PSUR)

• Depending on the type of device and any post-market issues, you may be required to submit a Periodic Safety Update Report (PSUR). This report should:
  • Summarize the safety and effectiveness of the device.
  • Analyze any post-market incidents or adverse events and corrective actions taken.
  • Provide an updated risk-benefit assessment of the device.

2. Device Labeling and Instructions for Use (IFU)

2.1 Ensure Accurate and Updated Labeling

• All device labeling, including packaging and instructions, must comply with SFDA requirements. Ensure your labels are:
  • In both Arabic and English (mandatory).
  • Updated with accurate and compliant information about the device’s intended use, warnings, and contraindications.
• Any changes in labeling must be submitted to SFDA for approval.

2.2 IFU and User Manual Compliance

• The Instructions for Use (IFU) must be in Arabic and English.
  • The IFU should include accurate instructions on device operation, safety precautions, potential side effects, and maintenance.
  • Any changes or updates to the IFU must be communicated to SFDA before being marketed.

3. Regulatory Updates and Compliance

3.1 Monitor Regulatory Changes

• Stay up to date with any changes to SFDA’s regulations or standards for medical devices, including any updates to the Medical Device Regulations (MDR) or new guidance.
  • SFDA regularly issues updates on regulations, and as a device manufacturer or distributor, you must ensure that your device remains compliant with the latest rules and standards.

3.2 Re-registration and Renewals

• Annual registration renewal: B-class medical device registrations are typically valid for one year. Before the end of the registration period, you will need to submit renewal applications to SFDA to ensure your device continues to be authorized for sale in Saudi Arabia.
  • Updated documentation may be required during the renewal process, including:
    • Proof of continued compliance with SFDA’s requirements.
    • Updated quality control and safety data.
    • Any changes in the manufacturer, distributor, or other relevant details.

3.3 Device Modifications and Updates

• If there are any modifications to the device (e.g., design changes, updates to the manufacturing process, or material changes), you must notify SFDA. This may involve:
  • Submitting a new application or an amended registration.
  • Providing new documentation, including updated clinical data (if necessary) and risk management files.

3.4 Local Authorized Representative (LAR)

• If you have a local authorized representative (LAR) in Saudi Arabia, ensure they are informed of any updates regarding the device or the regulatory process.
• The LAR must manage all regulatory correspondence and facilitate inspections or audits as needed.

4. Inspections and Audits

4.1 SFDA Inspections

• SFDA may conduct periodic inspections of your device’s manufacturing facility or importation procedures, especially for B-class and higher-risk devices.
  • These inspections may assess quality management systems (QMS), good manufacturing practice (GMP) compliance, and other regulatory standards.
  • Be prepared for inspections by maintaining accurate records of your manufacturing processes and quality control procedures.

4.2 Product Testing

• If SFDA requires additional product testing or evaluation, you must ensure that the necessary procedures are followed.
  • This could involve testing for biocompatibility, electrical safety, sterility, or other performance characteristics.
  • Any testing results should be submitted to SFDA for review and approval.

5. Handling of Non-Compliance or Issues

5.1 Corrective Actions

• If issues are identified through market surveillance or SFDA inspections (e.g., device malfunctions, safety concerns, or labeling discrepancies), you may need to take corrective actions.
  • This can include product recalls, modifications to the device, or updates to the IFU and labeling.

5.2 Device Recalls and Market Withdrawals

• If a safety risk is identified, or the device is found to be non-compliant with regulations, SFDA may mandate a recall or market withdrawal.
  • Recall procedures: You must notify distributors, customers, and affected users, providing them with information on how to return or discontinue use of the device.
  • SFDA must be informed immediately, and you will need to provide an action plan for addressing the issue.

5.3 Corrective and Preventive Actions (CAPA)

• You must develop and implement a Corrective and Preventive Action (CAPA) plan in case of any adverse events, complaints, or safety issues related to your device.
  • Ensure that any corrective actions taken are documented and communicated to SFDA.
  • Evaluate the effectiveness of the corrective actions and update your processes to prevent recurrence.

6. Fees and Payments

6.1 Annual Renewal Fees

• You will need to pay annual renewal fees to SFDA to maintain your device’s registration. Ensure that these fees are paid on time to avoid suspension or revocation of the registration.

6.2 Additional Fees for Modifications

• If there are significant changes to your device or registration, SFDA may charge additional fees for reviewing and processing these changes.

7. Post-Market Reporting Requirements

7.1 Reporting Adverse Events

• As part of your post-market surveillance obligations, you must:
  • Report any adverse events related to the device to SFDA, particularly serious incidents (e.g., death, injury, or device malfunction).
  • Maintain a complaint handling system to address user concerns and incidents, and keep records of any complaints, investigations, and resolutions.

7.2 Periodic Updates to SFDA

• SFDA may request periodic reports to track the device’s performance and safety over time.
  • Be prepared to submit updated clinical data, performance data, or adverse event summaries.

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