After applying for Class D medical device registration in Saudi Arabia, the manufacturer and Local Authorized Representative (LAR) must continue to comply with various SFDA regulations and requirements to maintain the device’s market authorization and ensure ongoing patient safety.

Here’s a detailed overview of the key post-application regulatory obligations and requirements that apply after submitting your registration application:

Key Regulations and Requirements After Application Submission

1. Respond Promptly to SFDA Queries and Requests

• During the technical and administrative review, SFDA may request:

  • Additional documents or clarifications

  • Technical data or clinical evidence supplements

  • Labeling or IFU revisions

• Timely and comprehensive responses are crucial to avoid delays or rejection.

2. Maintain Communication Through the MDNR Portal

• Use the Medical Devices National Registry (MDNR) platform for all official communications.

• Monitor portal notifications regularly for updates, requests, or approvals.

• Keep contact details current and ensure the LAR is reachable.

3. Compliance with Post-Market Surveillance (PMS) Obligations

• SFDA expects manufacturers and LARs to have an effective PMS system in place, including:

  • Adverse event reporting mechanisms

  • Field Safety Corrective Actions (FSCA) management

  • Trend analysis and safety signal detection

• Even during application review, PMS systems must be prepared.

4. Adherence to Labeling and IFU Standards

• Any changes to device labeling or IFU after application submission require SFDA notification.

• Labels and IFU must remain compliant with bilingual and content requirements.

• Unapproved modifications can lead to enforcement actions.

5. Device Modifications and Change Control

• Report significant changes to the device’s design, intended use, manufacturing site, or materials during the application process.

• Some changes may require:

  • Supplementary submissions

  • New registration applications

6. Maintain Establishment License Validity

• Ensure that the manufacturer’s and LAR’s Establishment Licenses (EL) remain valid throughout the review.

• Expiry or cancellation of EL can pause or terminate the application.

7. Compliance with Import and Customs Procedures

• Although device marketing authorization (MDMA) is required before import, preparations for customs clearance via the SABER platform should be initiated.

• Ensure import documentation is consistent with registration information.

8. Prepare for Possible SFDA Audits

• SFDA may conduct on-site audits of manufacturing facilities or the LAR during or after application review.

• Maintain readiness by:

  • Keeping Quality Management Systems up to date

  • Documenting complaint handling and PMS

  • Ensuring traceability of device lots

9. Adherence to Saudi Arabian Standards

• Stay updated on any changes to SFDA regulations, standards, or guidance during application review.

• Non-compliance with updated requirements may delay approval.

10. Confidentiality and Intellectual Property Protection

• Ensure sensitive technical and clinical information submitted to SFDA is protected.

• Use non-disclosure agreements (NDAs) with partners and LARs as needed.

Summary Table of Post-Application Responsibilities

If you want, I can help draft templates for SFDA query responses, advise on setting up a PMS system, or assist with MDNR and SABER platform navigation during the post-application phase.