Procedures for Class C Medical Device SFDA Registration

1. Appoint a Saudi Authorized Representative (AR)

   • Non-Saudi manufacturers must appoint a Saudi-based Authorized Representative (AR) who holds an SFDA Medical Device Establishment License (MDEL).
   • The AR will manage the submission and communication with the SFDA.

2. Prepare Documentation and Technical File

   • Gather all required documentation and compile the technical file. Ensure that all documents meet SFDA requirements and are in the appropriate format for submission through the GHAD system.

3. Register on the SFDA GHAD Portal

   • Both the manufacturer and the AR must register on the GHAD portal. This is SFDA’s e-service platform for managing medical device applications.
   • Create and complete profiles for both the manufacturer and the device.

4. Submit the Medical Device Marketing Authorization (MDMA) Application

   • Submit the MDMA application through the GHAD system. Include all required documents and ensure accuracy and completeness.

5. Pay Registration Fees

   • Pay the applicable fees through the GHAD system. Fees cover the SFDA’s review and evaluation process.

6. Respond to SFDA Queries

   • If the SFDA requests additional information or clarification, respond promptly through the GHAD portal to avoid delays.

7. Receive SFDA Approval

   • Once the review is completed and the device is approved, the SFDA will issue a Medical Device Marketing Authorization (MDMA).

8. Post-Market Obligations

   • After receiving MDMA, comply with post-market obligations, including adverse event reporting and post-market surveillance.

Required Materials for Class C Medical Device Registration

1. Technical File (Dossier)

   • Device Description: Comprehensive information about the device, its intended use, and design.
   • Manufacturing Information: Details of the manufacturing process, materials used, and quality control.
   • Risk Management File: Documented risk analysis and management according to ISO 14971.
   • Clinical Evaluation: Clinical data demonstrating the device's safety and performance.
   • Testing Reports: Results of safety and performance tests (e.g., biocompatibility, electrical safety).
   • Labeling and Instructions for Use (IFU): Labels and user instructions in both Arabic and English.
   • Declaration of Conformity: Manufacturer's declaration of compliance with relevant standards and regulations.

2. Quality Management System (QMS) Certification

   • Proof of QMS certification, typically ISO 13485.

3. Regulatory Approvals from Other Jurisdictions

   • Previous approvals from trusted regulatory bodies (e.g., CE Marking, FDA clearance).

4. Saudi Authorized Representative Information

   • Details of the appointed AR, including their SFDA Medical Device Establishment License (MDEL).

5. Post-Market Surveillance (PMS) Plan

   • A plan outlining how the device's safety and performance will be monitored after market introduction.

Precautions for Class C Medical Device SFDA Registration

1. Accuracy and Completeness

   • Ensure all documentation is complete, accurate, and complies with SFDA guidelines. Incomplete or inaccurate submissions can lead to delays or rejection.

2. Translation Requirements

   • All labeling and instructions for use must be provided in both Arabic and English. Ensure accurate translation to avoid compliance issues.

3. Authorized Representative Compliance

   • Ensure that the AR is properly licensed and capable of handling post-market obligations, including adverse event reporting.

4. Document Format and Upload

   • Follow the SFDA’s specific requirements for document format and upload through the GHAD system to prevent technical issues.

5. Timely Responses

   • Respond promptly to any SFDA requests for additional information to avoid delays in the review process.

6. Regulatory Updates

   • Stay updated on any changes in SFDA regulations or guidelines to ensure ongoing compliance.

7. Fee Payments

   • Ensure that all fees are paid on time and that payment transactions are correctly processed through the GHAD system.

8. Quality Management

   • Maintain robust quality management practices and ensure that the device meets international standards to support a successful registration.

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