For periodic renewal of Class D medical device registration in Saudi Arabia, the Saudi Food and Drug Authority (SFDA) has clear standards and procedures to ensure continued compliance, safety, and performance of high-risk devices on the market.

🕒 Renewal Standards and Timeline

• Validity Period:
  Typically, the Medical Device Marketing Authorization (MDMA) for Class D devices is valid for 5 years from the date of issuance.

• Renewal Timeline:
  Renewal applications should be submitted at least 90 days (3 months) before the expiry date of the existing registration to avoid lapses in authorization.

📋 Renewal Requirements and Documentation

To successfully renew your Class D device registration, you must submit updated and complete documentation demonstrating ongoing compliance:

1. Renewal Application Form

• Completed via the MDNR portal.

• Confirm or update all registration details.

2. Post-Market Surveillance (PMS) Report

• Summary of PMS activities since last registration or renewal.

• Includes adverse event data, complaints, FSCA actions, and trend analysis.

• Demonstrates continuous safety monitoring.

3. Updated Clinical Evaluation Report (CER)

• Reflects new clinical data, literature, or post-market clinical follow-up (PMCF).

• Supports device safety and performance claims.

4. Declaration of Conformity (DoC)

• Signed by the manufacturer, confirming compliance with applicable standards.

• Should reference up-to-date standards and regulatory requirements.

5. Current Quality Management System (QMS) Certificate

• Valid ISO 13485:2016 certification from an SFDA-recognized body.

• Certificate scope must cover the device and manufacturing sites.

6. Labeling and Instructions for Use (IFU)

• Provide updated bilingual labeling if any changes occurred.

• Confirm continued compliance with SFDA requirements.

7. Proof of Payment of Renewal Fees

• Pay applicable SFDA renewal fees via MDNR or SFDA-designated channels.

8. Other Supporting Documents

• Changes to device design, manufacturing process, or site (if applicable).

• Updated Establishment License (EL) for manufacturer and LAR.

🔄 Renewal Procedure Step-by-Step

⚠️ Important Considerations

• Late Renewal:
  Submitting renewal after expiry may lead to:

  • Suspension of marketing authorization

  • Requirement to reapply as a new registration (longer process)

• Changes in Device or Manufacturer:
  Significant changes since the last registration may require:

  • Supplemental submissions or a new registration process

  • Additional clinical or technical data

• Maintain Establishment License Validity:
  EL must be valid during renewal; renew EL separately if needed via the GHAD portal.

Summary Table: Renewal Requirements

If you want, I can help you with a step-by-step guide for the MDNR renewal portal, templates for PMS reports or CER updates, or checklist to prepare all necessary documents for smooth renewal of your Class D device registration in Saudi Arabia.