Post-market surveillance (PMS) plays a critical role in maintaining the safety, quality, and performance of medical devices available in Saudi Arabia. The Saudi Food and Drug Authority (SFDA) enforces clear and structured requirements under the “Medical Devices – Post Market Surveillance Requirements” (MDS-REQ 11) to ensure ongoing monitoring once devices are placed on the market.

This article outlines the key PMS requirements that manufacturers, authorized representatives, importers, and distributors must follow in Saudi Arabia.

Post-Market Surveillance (PMS) Requirements of Medical Devices in SFDA

1. Establishing a Post-Market Surveillance System

Manufacturers and authorized representatives must establish and maintain a systematic PMS process that is proportionate to the risk associated with the device. The PMS system should include:

• Procedures for gathering information on device performance.
• Analysis of post-market experience.
• Actions based on findings, including field safety corrective actions (FSCAs) if needed.

The system must be documented and available for inspection by the SFDA upon request.

2. Reporting of Adverse Events and Incidents

Manufacturers are obligated to report any incident that has led to, or could potentially lead to, serious health deterioration or death. Key points include:

• Initial reporting: Serious incidents must be reported to SFDA immediately once identified, with timelines depending on the severity:
  • 2 calendar days for incidents posing an imminent risk of death or serious injury.
  • 10 calendar days for incidents that resulted in death or unanticipated serious deterioration of health.
  • 15 calendar days for other reportable incidents.

Manufacturers must also submit follow-up and final reports after investigating the cause of the incident.

3. Field Safety Corrective Actions (FSCA)

If a manufacturer identifies a need for corrective action after devices have been distributed, they must:

• Inform SFDA before initiating the action, unless immediate action is required to protect public health.
• Distribute a Field Safety Notice (FSN) to all affected users, explaining the corrective action in clear and accessible language.
• Maintain documentation of all FSCAs.

SFDA must approve FSNs before distribution unless urgent circumstances exist.

4. Trend Reporting

Manufacturers must monitor and report statistically significant increases in the frequency or severity of incidents or potential issues, even if they are not individually reportable. This helps SFDA detect broader problems early.

Trend reports should:

• Use predefined thresholds and methodologies.
• Be based on the PMS plan and device risk classification.

5. Responsibilities of Economic Operators

In Saudi Arabia, economic operators have distinct PMS responsibilities:

• Manufacturers: Responsible for setting up and managing the PMS system and fulfilling reporting obligations.
• Authorized Representatives: Act on behalf of manufacturers outside the Kingdom, ensuring PMS compliance.
• Importers and Distributors: Must report complaints or adverse events to the manufacturer and assist with investigations. They must also ensure traceability and provide support during recalls.

6. Documentation and Record Keeping

All PMS activities must be documented thoroughly, including:

• Complaint records.
• Investigation reports.
• Incident notifications.
• Records of FSCA implementation.
• Trend reports.

Manufacturers must retain these records for at least ten (10) years after the last device has been placed on the market, or fifteen (15) years for implantable devices.

7. PMS Plan and Periodic Safety Update Reports (PSURs)

Manufacturers are expected to maintain a PMS plan specific to each device or device family, which should include:

• Methods for data collection and analysis.
• Criteria for evaluating incidents and trends.
• Actions based on findings.

For higher-risk devices (Class C and D), manufacturers must submit a Periodic Safety Update Report (PSUR) to SFDA summarizing safety and performance data regularly.

8. Communication with SFDA

Manufacturers, authorized representatives, and other economic operators must respond promptly to SFDA requests for additional information, including:

• PMS documentation.
• Risk assessments.
• Corrective action plans.

Failure to comply can lead to regulatory actions, including withdrawal of market authorization.

You can also refer this video –

How OMC Medical Can Help

OMC Medical supports manufacturers, authorized representatives, importers, and distributors in meeting Saudi Arabia’s post-market surveillance requirements.

We help set up compliant PMS systems, manage incident reporting and corrective actions, prepare PSURs for high-risk devices, and maintain required documentation. We also liaise with the SFDA on your behalf and ensure your local partners understand and fulfill their obligations.

With OMC Medical, you can stay compliant, protect your market access, and focus on delivering safe, high-quality devices.

Conclusion

Post-market surveillance requirements in Saudi Arabia are detailed and strictly enforced to protect public health. Manufacturers must invest in robust PMS systems, ensure timely incident reporting, and maintain clear communication with SFDA.
Compliance with MDS-REQ 11 is not only a legal obligation but also critical to sustaining market access and ensuring the continued safety of medical devices in the Kingdom.