The process for D-class medical device registration with the Saudi Food and Drug Authority (SFDA) involves several steps to ensure compliance with the regulatory requirements. D-class medical devices are typically low-risk devices, but they still need to meet certain criteria for safety and performance before they can be marketed in Saudi Arabia. Below is a detailed breakdown of the registration process and the steps involved:

1. Determine Device Classification

• Determine Classification: Before starting the registration process, ensure that your device qualifies as a D-class medical device (low risk). D-class devices are generally non-invasive, with minimal risk to users. This classification is based on the device's intended use and the risks it poses to patients or users.
• Check SFDA's Classification Rules: Refer to the SFDA’s Medical Device Classification guidelines to confirm the classification of your device. If unsure, seek consultation with a regulatory expert.

2. Appoint a Saudi Local Authorized Representative (LAR)

• If the manufacturer is not located in Saudi Arabia, they must appoint a Local Authorized Representative (LAR) who is based in the country. The LAR will handle the registration process, communication with the SFDA, and act as the point of contact for post-market surveillance.
• LAR Responsibilities: The LAR is responsible for ensuring compliance with SFDA regulations, submitting the registration application, and handling any regulatory queries or actions related to the device.

3. Prepare Required Documentation

The following documents must be prepared for the registration application:

• Device Description: A clear and concise description of the device, its intended use, and its classification.
• Manufacturing Details: Information about the manufacturer, including the company name, address, and contact information.
• Quality Management System (QMS) Certification: The device must comply with Good Manufacturing Practices (GMP). A copy of the ISO 13485 certification or an equivalent quality management system certificate is typically required.
• Risk Management File: A risk management file that demonstrates the safety and effectiveness of the device, in line with ISO 14971.
• Clinical Data (if applicable): For some devices, particularly if there is a claim of medical efficacy, clinical data supporting the safety and performance of the device may be required. However, D-class devices may have fewer requirements in this area.
• Device Labeling: This includes the device name, manufacturer details, intended use, and warnings, as well as an Instruction for Use (IFU) in both Arabic and English.
• Technical Documentation: Depending on the device, additional documentation may be required, such as electrical safety, biocompatibility reports, or performance testing results.

4. Submit the Application

• Application Submission: The registration application is submitted through the Saudi Drug Registration System (SDRS), which is the online platform for submitting medical device registrations to the SFDA.
• Required Fields: During the submission, the following details need to be provided:
  • Device classification, name, and description.
  • Manufacturer and LAR information.
  • Copies of all required documentation (QMS, labeling, risk management, etc.).
• Payment of Fees: Along with the application, the required registration fees must be paid. These fees may vary depending on the type of device and its classification.

5. SFDA Review and Evaluation

• Once the application is submitted, the SFDA will review the provided documents to assess whether the device meets the regulatory requirements.
• Documentation Review: The SFDA will check the completeness and accuracy of the documentation. If any documents are missing or inadequate, they will request additional information or corrections.
• Compliance Check: The SFDA ensures that the device complies with local regulations, such as risk classification, labeling, quality management standards, and post-market surveillance requirements.

6. SFDA Decision

After reviewing the application and supporting documents, the SFDA will issue one of the following decisions:

• Approval: If the device meets all the regulatory requirements, the SFDA will approve the registration, and the device will be granted access to the Saudi Arabian market.
• Request for Additional Information: If any documentation is incomplete or unclear, the SFDA will request additional information or clarification before proceeding with the approval.
• Rejection: If the device does not meet the regulatory requirements or fails to meet safety or performance standards, the application may be rejected.

7. Issuance of Registration Certificate

• Once the device is approved, the SFDA will issue an official registration certificate for the D-class medical device. This certificate serves as proof of compliance and authorization to market the device in Saudi Arabia.
• The registration number and expiration date will also be provided.

8. Post-Market Surveillance Requirements

• Ongoing Monitoring: After the device is registered and available in the market, the manufacturer and LAR must comply with SFDA’s post-market surveillance (PMS) requirements, including:
  • Adverse event reporting: Any safety issues, defects, or complaints related to the device must be reported to the SFDA.
  • Periodic Reporting: Depending on the device, the SFDA may require periodic safety or performance reports.
• Recalls: If any serious issues arise post-market, the device may be recalled from the market, and corrective actions will need to be taken.

9. Annual Registration Renewal

• Annual Renewal: D-class medical devices are subject to annual registration renewal with the SFDA. Manufacturers or LARs must submit updated documents and pay the renewal fees.
• Updated Information: Any significant changes in the device or its manufacturing process must be reported during the renewal process.

10. Compliance with Additional Requirements

• Labeling Compliance: Ensure that the device's labeling (including packaging and IFU) is in compliance with Saudi regulations, including both Arabic and English language requirements.
• Quality Management System (QMS): The manufacturer must maintain compliance with the QMS standards (ISO 13485 or equivalent) and be prepared for SFDA inspections or audits if necessary.

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