After obtaining Class D medical device registration in Saudi Arabia, there are several important post-registration obligations and best practices to ensure continued compliance with Saudi Food and Drug Authority (SFDA) regulations and maintain the device’s market authorization. Here’s what you should note:

Key Post-Registration Considerations for Class D Medical Devices in Saudi Arabia

1. Maintain Valid Establishment License (EL)

• Both the manufacturer and the Local Authorized Representative (LAR) must keep their Establishment Licenses valid.

• Renew licenses before expiry via the GHAD platform.

• Any changes in company ownership or address must be reported promptly to SFDA.

2. Medical Device Marketing Authorization (MDMA) Validity and Renewal

• The MDMA certificate issued after registration is valid for a limited period (typically 3 to 5 years).

• Apply for renewal at least 90 days before expiry through the MDNR platform.

• Renewal requires submission of updated documentation including:

  • Post-market surveillance (PMS) reports

  • Updated clinical evaluation or safety data

  • Evidence of continued compliance with applicable standards

3. Post-Market Surveillance (PMS) and Vigilance

• Establish and maintain a PMS system compliant with SFDA requirements.

• Monitor device performance, collect adverse event reports, and perform trend analysis.

• Report any serious adverse events, field safety corrective actions (FSCA), or recalls to SFDA within the stipulated timeframe.

• Maintain records of complaints, investigations, and corrective actions.

4. Labeling and IFU Compliance

• Ensure that all marketed devices continue to comply with SFDA’s bilingual labeling (Arabic and English) and IFU requirements.

• Any changes to labeling or instructions must be notified to SFDA and may require prior approval.

5. Device Modifications and Variations

• Report any significant changes to the device design, intended use, manufacturing process, or labeling to SFDA.

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

• Minor changes should still be documented in your quality system and communicated as required.

6. Import and Customs Clearance

• Register each shipment via the SABER platform for customs clearance.

• Ensure product compliance with the declared MDMA and maintain traceability documentation.

7. SFDA Inspections and Audits

• Be prepared for SFDA inspections of manufacturing sites, distribution centers, or LAR offices.

• Maintain readiness by keeping your QMS, PMS records, and technical documentation up to date.

• Non-compliance found during inspections can lead to suspension or cancellation of registration.

8. Communication with SFDA

• Monitor and respond promptly to all SFDA communications through the MDNR portal.

• Update contact information and ensure the LAR is accessible for regulatory correspondence.

9. Compliance with Saudi Arabian Standards and Regulations

• Stay updated on any changes in SFDA regulations, standards, or guidance documents relevant to medical devices.

• Participate in SFDA training or workshops when applicable.

10. Market Withdrawal and Recall Procedures

• Have robust procedures in place to execute voluntary or mandatory market withdrawals or recalls.

• Communicate effectively with distributors, healthcare providers, and patients as required.

Summary Table of Post-Registration Obligations

If you want, I can help prepare templates for post-market surveillance reports, guide you on setting up a vigilance system, or assist with MDMA renewal submissions through SFDA portals.

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