To apply for D-class medical device registration with the Saudi Food and Drug Authority (SFDA), you need to follow a structured process and submit your application through the Mysfda portal, which is the official online system for medical device registration in Saudi Arabia.

Here’s a step-by-step guide on how to apply for D-class medical device registration and where to handle the application:

1. Create an Account on Mysfda Portal

• Portal Access: Go to the Mysfda portal: https://www.sfda.gov.sa/en.
• Register an Account: If you don't already have an account, you will need to register as either a local authorized representative or a manufacturer. You will need a valid email address and business details to create your account.
  • For foreign manufacturers, a local authorized representative must be appointed in Saudi Arabia to handle the registration.

2. Complete the Application Form

• Login to your Mysfda account.
• Select Medical Device Registration: Navigate to the "Medical Devices" section in the portal and select D-class medical devices for registration.
• Fill in the Application Form: Complete the online application form with all relevant information about your medical device, including:
  • Device Name and Model
  • Manufacturer Details (name, address, contact info)
  • Device Classification (confirm that it is a D-class device)
  • Intended Use (for example, implantable, life-supporting)
  • Risk Classification (based on SFDA classification criteria)

3. Prepare and Upload Required Documents

• The following documents must be prepared and uploaded in the portal:
  1. Device Description: Detailed specifications, components, and intended use of the device.
  2. Clinical Evaluation Report: If applicable, provide clinical data, trials, and post-market follow-up data.
  3. Risk Management Documentation: Including risk assessments following ISO 14971.
  4. Conformity Assessment: Evidence of compliance (CE Mark, FDA approval, etc.).
  5. ISO 13485 Certification: Proof of a quality management system that complies with international standards.
  6. Good Manufacturing Practice (GMP) Compliance: Documentation proving the manufacturer follows GMP.
  7. Labeling: Device labeling, including instructions for use (IFU).
  8. Quality Control Procedures: Documentation of the manufacturer's processes for ensuring device quality.

4. Pay the Registration Fee

• After completing the application and uploading all required documents, you will be prompted to pay the registration fees. The fees can be paid online through the Mysfda portal.
• Fee Structure: The fee varies depending on the device's classification and complexity, with D-class devices generally having higher fees due to their high-risk status.

5. Submit the Application

• Once the form is filled out and the required documents are uploaded, you can submit the application for review.
• SFDA Evaluation: The SFDA will evaluate your submission to ensure it meets all regulatory requirements for safety, efficacy, and quality.
  • If additional information or clarification is required, the SFDA will contact you.
  • You may also need to undergo an on-site inspection of your manufacturing facilities if the device is classified as high-risk.

6. Track the Status of the Application

• You can track the progress of your application through the Mysfda portal. The status updates will indicate whether your application is under review or if additional documents are required.
• Review Time: The review process for D-class devices can take several months (typically 3 to 6 months) due to the complexity and higher-risk classification.

7. Receive Registration Approval

• If your device meets the requirements, you will receive an SFDA Registration Certificate that authorizes you to market and sell the device in Saudi Arabia.
• Validity: The registration certificate is typically valid for one year, after which you must apply for renewal.

8. Post-Market Surveillance and Compliance

• After registration, you will be subject to ongoing post-market surveillance requirements, including:
  • Reporting adverse events or device malfunctions to SFDA.
  • Periodic Safety Update Reports (PSUR).
  • Product Recalls (if needed).

Where to Handle the Application:

• Mysfda Portal: The entire registration process is handled through the Mysfda portal. It is the central platform for medical device registrations in Saudi Arabia.

  • Website: Mysfda Portal

• Local Authorized Representative: If you are a foreign manufacturer, your local authorized representative in Saudi Arabia will be responsible for submitting the application and managing all communications with the SFDA. Ensure your representative is registered with the SFDA.

• SFDA Medical Device Sector: The Medical Device Sector within the SFDA will review your application. You can contact them directly through the SFDA website if you need additional guidance during the process.

Summary of Key Steps:

1. Create an Account on Mysfda portal.
2. Complete the application form with device details and manufacturer information.
3. Upload required documents such as clinical data, risk management, quality certifications, and GMP compliance.
4. Pay the registration fee through the portal.
5. Submit the application for SFDA review.
6. Track the application status via the portal.
7. Receive approval and SFDA registration certificate.

By following these steps, you can successfully apply for D-class medical device registration in Saudi Arabia through the Mysfda portal. Ensure that all documentation is complete and meets SFDA guidelines to avoid delays during the review process.

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