Before applying for Class C medical device SFDA registration in Saudi Arabia, several preparations are crucial to ensure a smooth and successful application process. Here’s a comprehensive checklist to guide you through the preparations:

Preparations Before Applying for Class C Medical Device SFDA Registration

1. Understand SFDA Requirements

   • Regulations and Guidelines: Review the SFDA regulations and guidelines for medical device registration. Familiarize yourself with the requirements specific to Class C devices.
   • Technical Guidance: Obtain and study the SFDA’s technical guidance documents related to Class C medical devices.

2. Appoint a Saudi Authorized Representative (AR)

   • Selection: Identify and appoint a qualified Saudi Authorized Representative (AR) who is licensed by the SFDA. The AR will handle the registration process and ensure compliance with local regulations.

3. Develop a Comprehensive Technical File

   • Device Description: Prepare detailed documentation on the device’s design, intended use, and specifications.
   • Manufacturing Information: Compile information on the manufacturing process, quality control, and facility details.
   • Risk Management: Document risk management practices following ISO 14971.
   • Clinical Evaluation: Collect clinical data and prepare a clinical evaluation report.
   • Testing Reports: Include results from relevant safety and performance testing.
   • Labeling and IFU: Ensure that labeling and Instructions for Use (IFU) are prepared in both Arabic and English.

4. Ensure Compliance with International Standards

   • ISO Certifications: Obtain and review certifications such as ISO 13485 for quality management systems and ISO 10993 for biocompatibility, as applicable.
   • IEC Standards: For electrical devices, ensure compliance with IEC 60601 series standards.

5. Prepare for Post-Market Surveillance

   • Plan Development: Develop a post-market surveillance plan outlining how you will monitor the device’s performance and safety after it is on the market.

6. Gather Regulatory Approvals from Other Jurisdictions

   • Evidence of Approvals: If the device has been approved in other regions (e.g., CE Marking, FDA clearance), gather and prepare documentation of these approvals.

7. Documentation and Record Keeping

   • Documentation Preparation: Ensure that all required documents are complete, accurate, and organized. This includes preparing electronic files if required by the SFDA’s GHAD portal.
   • Record Keeping: Maintain thorough records of all documents, correspondence, and submissions related to the registration process.

8. Financial and Administrative Preparations

   • Fee Payment: Prepare for the payment of registration fees. Ensure you understand the fee structure and have the necessary funds available.
   • Application Form: Complete the SFDA application form accurately, ensuring all required fields are filled out.

9. Training and Support

   • Staff Training: Train relevant staff on the regulatory requirements and documentation processes for SFDA registration.
   • Consultation: Consider consulting with a regulatory affairs expert to review your preparation and documentation before submission.

10. Submit Application

    • GHAD Portal: Familiarize yourself with the SFDA’s GHAD portal for electronic submission. Ensure that all documents and forms are submitted according to the SFDA’s requirements.

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