Applying for Class C medical device SFDA registration in Saudi Arabia involves a series of structured processes to ensure that the device meets the regulatory standards set by the Saudi Food and Drug Authority (SFDA). Here’s a detailed overview of the processes involved:

Processes for Applying for Class C Medical Device SFDA Registration

1. Pre-Application Preparations

   • Understand SFDA Requirements: Review SFDA regulations and guidelines for Class C medical devices. Ensure you are aware of all the specific requirements and standards.

   • Appoint a Saudi Authorized Representative (AR): If you do not have a local presence, appoint a qualified AR who will act as your representative in Saudi Arabia and handle the registration

   • process.

2. Prepare Required Documentation

   • Technical File: Compile the necessary documentation, including:
     • Device Description: Detailed information about the device, its intended use, and its classification.
     • Design and Manufacturing Information: Details on the device’s design, manufacturing processes, and quality control measures.
     • Risk Management: Documentation demonstrating compliance with ISO 14971, including risk assessment and management plans.
     • Clinical Evaluation: Clinical data or literature supporting the device’s safety and efficacy.
     • Testing Reports: Results from safety, performance, and biocompatibility tests.
   • Quality Management System (QMS): Documentation of compliance with ISO 13485.
   • Labeling and Instructions for Use (IFU): Ensure labeling and IFU are provided in both Arabic and English, adhering to SFDA requirements.

3. Complete the Application Form

   • Access the GHAD Portal: Log in to the SFDA’s GHAD (Generic Health and Drug) portal, which is used for submitting medical device registrations.
   • Fill Out the Application: Complete the medical device registration application form with accurate and comprehensive information.

4. Submit the Application

   • Upload Documents: Upload all required documentation to the GHAD portal. Ensure that all documents are in the correct format and meet SFDA requirements.
   • Submit the Application: Submit the application form and all associated documents electronically through the GHAD portal.

5. Pay Registration Fees

   • Fee Payment: Pay the applicable registration fees as outlined by the SFDA. Payment details and instructions will be provided during the submission process.
   • Receipt: Obtain and retain proof of payment for your records.

6. Review Process

   • Initial Screening: SFDA will conduct a preliminary screening to ensure that the application and documents are complete.
   • Technical Review: SFDA will perform a detailed technical review of the submitted documentation, including assessing compliance with safety, efficacy, and performance standards.
   • Requests for Additional Information: Be prepared to respond to any requests from SFDA for additional information or clarifications during the review process.

7. Approval and Issuance of Certificate

   • Decision: After completing the review, SFDA will make a decision on the application. If approved, you will receive a registration certificate.
   • Certificate: The registration certificate allows you to market the device in Saudi Arabia. Ensure that you keep a copy of this certificate and comply with any conditions specified.

8. Post-Market Obligations

   • Post-Market Surveillance: Implement a post-market surveillance plan to monitor the device’s performance and report any adverse events to the SFDA.
   • Compliance: Adhere to any additional requirements or conditions outlined by the SFDA in the registration certificate.

9. Renewal and Amendments

   • Renewal: Track the expiration date of your registration and prepare for the renewal process well in advance.
   • Amendments: If there are any changes to the device or its intended use, submit an amendment application to SFDA for approval.

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