Before applying for Class C medical device registration in Saudi Arabia, thorough preparation is essential to ensure a smooth application process and increase the likelihood of swift approval by the Saudi Food and Drug Authority (SFDA). Here’s a detailed checklist of key preparations you should complete before submitting your registration:

📝 Preparations Before Applying for Class C Medical Device Registration

1. Understand Device Classification and Regulatory Requirements

• Confirm that your device is properly classified as Class C according to SFDA’s medical device classification rules.

• Review the latest SFDA medical device regulations and guidance documents relevant to Class C devices.

• Familiarize yourself with SFDA’s Essential Principles of Safety and Performance.

2. Appoint a Saudi Authorized Representative (AR)

• Identify and contract with a qualified Saudi Authorized Representative who is registered with SFDA and holds a valid Establishment License (EL).

• Formalize the relationship through a Legal Representation Agreement (LRA).

• Ensure the AR understands their regulatory responsibilities including communication with SFDA and post-market obligations.

3. Obtain or Prepare Establishment Licenses (EL)

• Both the manufacturer (if applicable) and the Saudi AR must apply for and obtain Establishment Licenses via the SFDA’s GHAD system.

• Prepare all necessary company documents such as commercial registration, ISO 13485 certificates, and organizational charts.

• EL must be approved before device registration submission.

4. Compile Comprehensive Technical Documentation

• Assemble a complete technical file in compliance with SFDA requirements, structured according to IMDRF/GHTF guidelines.

• Include:

  • Device description and specifications

  • Risk management file (ISO 14971)

  • Clinical evaluation report (CER)

  • Declaration of conformity

  • Labeling and instructions for use (IFU) in Arabic and English

  • Quality management system certificate (ISO 13485)

  • Certificates of Free Sale (FSC) or equivalent market approvals

• Translate labeling and IFU accurately into Arabic.

5. Verify Quality Management System (QMS) Compliance

• Ensure your manufacturing facility is certified under ISO 13485.

• Confirm that your QMS covers the design, manufacture, and post-market activities related to the device.

6. Prepare Labeling and Packaging

• Design compliant labels, packaging, and IFU in both Arabic and English.

• Include mandatory information such as device name, model, lot number, manufacturer details, expiration date, warnings, and UDI (if applicable).

• Ensure clarity and accuracy to avoid delays.

7. Collect Clinical Evidence

• Prepare a robust Clinical Evaluation Report (CER) demonstrating safety and performance.

• Use clinical data, literature, equivalence studies, or post-market surveillance data as appropriate.

• Ensure adherence to MEDDEV 2.7.1 Rev. 4 or equivalent SFDA guidance.

8. Confirm Regulatory Approvals in Other Jurisdictions (If Any)

• Gather existing certificates such as CE marking, FDA 510(k), or TGA approvals.

• These can help facilitate an abridged review process with SFDA.

9. Plan for Application Submission and Fees

• Register your company and AR on the GHAD platform: https://ghad.sfda.gov.sa

• Prepare for payment of the registration fee (typically SAR 20,000–40,000).

• Ensure all documents are converted to PDF and properly named before upload.

10. Develop a Post-Market Surveillance (PMS) Plan

• Draft a plan for ongoing monitoring of device performance and safety in the Saudi market.

• Include mechanisms for complaint handling, incident reporting, and corrective actions.

📌 Summary Checklist Before Application

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