Requirements for D-Class Medical Device Registration with the Saudi SFDA

When applying for D-class medical device registration with the Saudi Food and Drug Authority (SFDA), it’s important to meet all necessary regulatory requirements to ensure the device is approved for sale in Saudi Arabia. D-class medical devices are categorized as low-risk devices, so the registration process is simpler compared to higher-risk devices, but certain key documents and standards still need to be met.

Here’s an overview of the requirements for applying for D-class medical device registration:

1. Appointment of a Local Authorized Representative (LAR)

• Foreign manufacturers must appoint a local authorized representative (LAR) who is licensed by the SFDA. This LAR will act as the point of contact between the SFDA and the manufacturer, submitting the registration application and ensuring ongoing compliance with Saudi regulations.
• The LAR must be based in Saudi Arabia and registered with the SFDA.

2. Device Classification Confirmation

• Confirm that your device falls under the D-class category. D-class medical devices are typically low-risk, non-invasive devices that pose minimal risk to patients and users.
• The classification of the device determines the regulatory requirements, and it is important that the device is appropriately classified according to SFDA’s guidelines.

3. Documentation Requirements

The following documentation is typically required for D-class medical device registration with the SFDA:

A. Manufacturer Information

• Legal entity proof: Business registration documents for the manufacturer.
• Manufacturing facility information: Documentation about the manufacturing site and compliance with Good Manufacturing Practices (GMP) or equivalent standards.

B. Device Information

• Device Description: Detailed description of the medical device, including its intended use, components, materials, and functioning.
• Risk Classification: Confirmation that the device is classified as a D-class device based on its risk profile.
• Intended Use: Clear explanation of the device’s purpose and application in medical settings.
• Device Design and Features: Information about the device’s design, technical specifications, and performance characteristics.

C. Labeling and Packaging Information

• Device Label: Labels must be provided in both Arabic and English, including product name, manufacturer information, intended use, storage conditions, and any warnings or instructions.
• User Manual/Instructions for Use (IFU): A copy of the user manual in both Arabic and English. It should include all necessary details for safe use, maintenance, and disposal of the device.

D. Quality Management System

• ISO 13485 Certification (or equivalent): This is a required certification to demonstrate that the manufacturer has implemented a quality management system compliant with international standards for medical devices.
• If the manufacturer is certified under ISO 13485 or another equivalent standard, a copy of the certification should be provided. This certifies that the manufacturer adheres to good manufacturing practices.

E. Certificate of Free Sale (CFS)

• Certificate of Free Sale: A certificate issued by the competent authority in the manufacturer’s home country, stating that the medical device is legally sold and marketed there. This document helps confirm that the device is already in circulation in another market and complies with local regulations.

F. Declaration of Conformity

• Declaration of Conformity: A formal statement from the manufacturer indicating that the device meets all applicable regulations and standards, such as ISO, IEC, and relevant local regulations. This declaration ensures the device complies with SFDA standards for safety and effectiveness.

G. Product Testing and Performance Data (if applicable)

• Depending on the device type, you may need to provide testing results or performance data. This could include:
  • Safety tests.
  • Electromagnetic compatibility (EMC) testing.
  • Biocompatibility testing (for devices in contact with the skin or body).
• However, for D-class devices (low-risk), the requirements for extensive testing might be limited, but some documentation or reports may still be required depending on the device type.

H. Clinical Data (if applicable)

• For some D-class devices, clinical data may be required to demonstrate the safety and effectiveness of the device. However, clinical data is typically less extensive than what is required for higher-risk devices (Class B, C, or D).
• Clinical studies may not be mandatory unless the device has a novel function or intended use.

4. Submission of Application

• The local authorized representative (LAR) submits the complete registration application and documents through the SFDA’s Medical Device Electronic Services (MDES) platform. This is the online portal for submitting all medical device registration applications.
• The application will include:
  • Completed registration form.
  • All required documents listed above.
  • Payment of the applicable registration fee.

SFDA fees for D-class devices are usually lower compared to higher-risk devices.

5. SFDA Review Process

• The SFDA will review the application to ensure the device meets the required safety and regulatory standards.
• D-class medical devices typically undergo a simplified review process compared to higher-risk devices.
• The review typically takes a few weeks, but this may vary depending on the complexity of the device and the completeness of the documentation.

6. Approval and Registration

• If the SFDA is satisfied with the application, they will issue the registration certificate for the device.
• The registration certificate allows the device to be legally marketed and sold in Saudi Arabia.
• Registration Validity: The registration certificate is typically valid for 5 years. After this period, you must apply for renewal.

7. Post-Market Surveillance

• After the device is registered, the manufacturer and their local representative must monitor the device’s performance in the market.
• Adverse events, complaints, or product recalls must be reported to the SFDA.
• The manufacturer must also cooperate with any SFDA inspections or audits.

8. Registration Renewal (Every 5 Years)

• The registration is valid for 5 years, after which the manufacturer must apply for renewal via the MDES platform.
• The renewal process involves ensuring that the device still meets SFDA requirements and submitting updated documentation if necessary.

Key Takeaways:

• The D-class registration process is generally simpler and faster compared to higher-risk devices.
• The local authorized representative (LAR) plays a crucial role in the process, especially for foreign manufacturers.
• Required documentation includes device information, quality management certification, labeling, free sale certificate, and other relevant data.
• Post-market surveillance and renewal are important for continued compliance with SFDA regulations.

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