After the approval of B-class medical device registration with the Saudi Food and Drug Authority (SFDA), there are several important aspects you need to pay attention to in order to maintain compliance with regulatory requirements and ensure the safe and effective use of the device in Saudi Arabia. These activities are part of ongoing post-market obligations and regulatory maintenance. Here's a detailed list of the key areas to focus on:

1. Post-Market Surveillance (PMS)

Once your device is on the market, you must continuously monitor its performance to ensure its ongoing safety and efficacy. This includes:

1.1 Adverse Event Reporting

• Report adverse events or incidents: If any adverse events (e.g., injuries, malfunctions, failures) related to your device occur, they must be reported to SFDA within the required timeframes.
  • Serious incidents (e.g., death or serious deterioration in health) must be reported immediately.
  • Non-serious incidents should be reported as soon as possible, usually within 15 days of becoming aware of the issue.

1.2 Vigilance System

• Implement a vigilance system for monitoring the device post-market. This includes:
  • Monitoring device performance and user feedback.
  • Tracking complaints and reporting issues back to SFDA.
  • Conducting regular evaluations to identify potential risks or areas for improvement.

1.3 Recalls and Corrective Actions

• If safety or performance issues arise that necessitate a recall or field safety corrective action (FSCA), it is your responsibility to coordinate with SFDA to ensure the device is recalled or corrected.
  • Recall plans must be in place, detailing how you will notify distributors, healthcare providers, and affected users.
  • Document all actions taken, including reasons for the recall, number of units affected, and corrective actions implemented.

2. Maintenance of Registration and Annual Fees

2.1 Annual Renewal of Registration

• After receiving approval for your device, you must renew the registration with SFDA periodically, typically annually. The renewal process often includes:
  • Submitting updated documentation if there have been any changes to the device or its manufacturing process.
  • Confirming the device’s continued compliance with SFDA requirements.

2.2 Payment of Fees

• Ensure that all annual registration fees are paid on time to avoid any interruptions in your device's market authorization.
  • These fees may vary depending on the device classification and the number of devices being registered.

2.3 Updates to Product Information

• If there are any changes to the product (e.g., design changes, new indications, manufacturing site changes), you must notify SFDA and submit updated documents for approval. Changes may require a new submission and review before continuing market availability.

3. Labeling and Instruction Updates

3.1 Labeling Compliance

• After approval, ensure that your device labeling, including the Instructions for Use (IFU), is updated regularly to comply with the most recent regulatory requirements.
  • Ensure that labeling is accurate, clear, and in Arabic and English, as required by SFDA.
  • Labeling must reflect any updates in device indications, contraindications, or warnings based on post-market data.

3.2 Translation and Local Requirements

• If SFDA requires further updates to your labeling (e.g., inclusion of new regulatory symbols or warnings), promptly update and submit these changes.
  • Ensure that any changes are also translated into Arabic if required by SFDA.

4. Reporting and Audits

4.1 Periodic Safety Update Reports (PSUR)

• Depending on the type of device, SFDA may request a Period Safety Update Report (PSUR). This report should summarize:
  • The safety and performance of the device based on post-market surveillance data.
  • Risk-benefit assessments of the device in the real-world use environment.
  • Any adverse events or complaints, and corrective actions taken.

4.2 SFDA Inspections and Audits

• SFDA may perform inspections of the manufacturing site or of the device itself to ensure ongoing compliance with regulatory requirements.
  • If you are an international manufacturer, SFDA may request access to the GMP certification of your manufacturing facilities or may conduct remote audits.

5. Market Surveillance and Monitoring

5.1 SFDA Market Surveillance Program

• SFDA actively monitors medical devices on the market through its market surveillance program. This includes:
  • Random inspections and sampling of medical devices.
  • Analysis of market trends and adverse events related to medical devices in the Saudi market.
  • Device-specific post-market clinical follow-up may be requested for certain high-risk devices.

5.2 Reporting Adverse Events and Field Safety Corrective Actions

• If there is a field safety corrective action (FSCA) or a device defect that needs to be addressed, you must report this to SFDA and follow the protocol for device recalls and corrections.
• Reports must be made within 15 days of receiving any notification regarding adverse events or safety issues.

6. Changes to the Device or Manufacturer Information

6.1 Device Modifications

• If you make any changes to the device (e.g., design, materials, or performance characteristics), you must submit an application for re-registration or modification of the registration to SFDA.
  • SFDA may require a new assessment of the device’s safety, performance, and compliance with regulations.

6.2 Change of Manufacturer or Distributor

• If there is a change in the manufacturer or the authorized representative for the device in Saudi Arabia, SFDA must be notified.
  • You may need to submit updated documents, including contracts and manufacturing certifications, to reflect the new arrangements.

7. Adherence to Local Regulatory Requirements

7.1 SFDA Regulatory Changes

• Stay updated on any changes in SFDA regulations or standards that may affect your device.
  • SFDA may periodically issue updates to its Medical Device Regulations (MDR) or introduce new regulatory guidelines that impact post-market surveillance, product safety, and device registration.

7.2 Coordination with Local Authorized Representative

• Ensure ongoing communication with your local authorized representative (LAR) in Saudi Arabia, who will assist you with regulatory updates, notifications, and any actions required by SFDA.

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