After obtaining Class C medical device registration (MDMA) in Saudi Arabia, manufacturers and their Saudi Authorized Representatives (AR) must comply with ongoing regulatory obligations to maintain market access and ensure device safety and effectiveness. These post-registration requirements are mandated by the Saudi Food and Drug Authority (SFDA) and include surveillance, reporting, compliance, and renewal duties.

Here is a comprehensive overview of the key regulations and requirements to follow post-registration:

1. Post-Market Surveillance (PMS) and Vigilance

• Implement an effective PMS system to continuously monitor device performance and safety once on the market.

• Collect and analyze data from users, complaints, clinical experience, and literature.

• Maintain records of all PMS activities.

• Submit Periodic Safety Update Reports (PSURs) or equivalent as required by SFDA.

• Update risk management files and clinical evaluation reports periodically based on PMS data.

2. Adverse Event and Incident Reporting

• Report serious adverse events (SAEs), incidents, malfunctions, or near misses related to the device to the SFDA promptly.

• The typical reporting timeline for serious events is within 15 calendar days of becoming aware.

• Investigate reported events and take corrective actions where necessary.

• Cooperate fully with SFDA investigations and provide requested documentation or samples.

3. Device Recalls and Corrective Actions

• Establish procedures for field safety corrective actions (FSCA), including recalls, safety notices, and product modifications.

• Notify SFDA immediately when a recall is initiated.

• Document the recall process and outcomes.

• Ensure communication with distributors, healthcare providers, and patients as appropriate.

4. Labeling and Instructions for Use (IFU) Updates

• Any changes to labeling, packaging, or IFU must be submitted for SFDA review and approval before distribution of the updated device.

• Labels and IFUs must continue to comply with SFDA requirements, including mandatory Arabic language content.

• Maintain consistency with device performance and safety information.

5. Change Management and Notification

• Notify SFDA of significant changes that could affect the device’s safety, performance, or intended use.

• Significant changes include manufacturing site changes, design modifications, or changes in sterilization methods.

• Some changes may require a supplemental registration application or new registration.

6. Establishment License (EL) Maintenance

• Both the manufacturer and the Saudi AR must maintain valid and active Establishment Licenses.

• EL renewal is generally required annually.

• Submit updated company and quality management information as needed.

7. Renewal of Medical Device Marketing Authorization (MDMA)

• The Class C device registration certificate is valid for 3 years.

• Submit renewal applications at least 3 to 6 months before expiry.

• Renewal requires updated technical documentation, PMS reports, and payment of fees.

• Failure to renew may result in suspension or cancellation of registration.

8. Compliance with Saudi Regulatory Updates

• Stay informed about any updates to SFDA regulations, guidelines, or standards.

• Adapt PMS, labeling, and QMS processes accordingly.

• Ensure all documentation and practices remain compliant.

9. Audit and Inspection Readiness

• Be prepared for SFDA audits of manufacturing sites, distribution facilities, and documentation.

• Maintain organized records of technical files, PMS data, complaints, and regulatory correspondence.

Summary Table: Post-Registration Compliance for Class C Devices

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