After obtaining Class C medical device registration (Medical Device Marketing Authorization, MDMA) in Saudi Arabia, there are several important post-registration responsibilities and compliance matters you must be aware of to maintain your registration and ensure ongoing market access.

Here’s a detailed rundown of the key post-registration obligations and considerations:

📌 Key Matters to Note After Registration

1. Validity and Renewal of Registration

• The MDMA certificate for Class C devices is typically valid for 3 years.

• Renewal applications should be submitted before expiry, usually 3–6 months in advance.

• Renewal requires updated technical documentation and payment of renewal fees.

2. Post-Market Surveillance (PMS) and Vigilance

• You must have an active Post-Market Surveillance system to monitor device safety and performance in the Saudi market.

• Regularly collect and analyze data from device users, complaints, and adverse events.

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

• SFDA may audit or request PMS data at any time.

3. Adverse Event Reporting and Recall Management

• You must report serious adverse events, incidents, or malfunctions to SFDA within mandated timelines (often within 15 calendar days for serious incidents).

• Maintain a system for field safety corrective actions (FSCA) including recalls, safety notices, or device modifications.

• Coordinate closely with your Authorized Representative (AR) in Saudi Arabia on all vigilance activities.

4. Labeling and Instructions for Use (IFU) Updates

• Any changes to labeling, packaging, or IFU, especially safety-related, must be reported and approved by SFDA before market introduction.

• Ensure Arabic translations remain accurate and compliant.

• Update your documentation and submit changes via the GHAD system.

5. Change Management

• Changes in manufacturing site, device design, intended use, or supplier must be notified to SFDA.

• Significant changes may require a new registration application or supplemental review.

• Minor changes should be documented internally and reported as required.

6. Importation and Distribution Compliance

• Only registered importers and distributors with valid Establishment Licenses may import or distribute your Class C device in Saudi Arabia.

• Ensure your supply chain partners comply with SFDA regulations and maintain traceability.

• Customs clearance is linked to your device registration and importer EL via SFDA’s DAD system.

7. Maintain Establishment License (EL)

• Both your company and your Authorized Representative must maintain valid and active ELs.

• ELs require annual renewal and compliance with SFDA standards.

8. SFDA Audits and Inspections

• SFDA may conduct random or scheduled inspections/audits of your manufacturing sites, quality system, or distribution facilities.

• Be prepared to provide access to quality records, PMS data, and registration documents.

9. Compliance with Saudi Standards and Regulations

• Stay updated on any changes in SFDA regulations, guidance documents, or standards that may affect your device.

• Non-compliance can result in suspension, withdrawal of registration, or penalties.

10. Communication with Authorized Representative (AR)

• Maintain a strong working relationship with your AR as they are your local regulatory liaison.

• AR is responsible for communication with SFDA, handling queries, and managing post-market obligations.

📌 Summary Table

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn