Class C Medical Device Registration with the Saudi SFDA

Class C medical devices are classified by the Saudi Food and Drug Authority (SFDA) as medium-risk devices. These devices are typically more complex than low-risk devices (Class A and B), but less risky than high-risk devices (Class D). For such devices, the SFDA requires a more thorough review and approval process to ensure safety and effectiveness.

Types of Class C Medical Devices

Class C devices can include but are not limited to:

• In vitro diagnostic devices (IVDs)
• Surgical instruments
• Implants
• Anesthesia equipment
• Diagnostic and therapeutic devices with moderate risks.

Regulatory Requirements for Class C Medical Devices

Before applying for registration, ensure that the device meets the following conditions:

1. Manufacturer’s Quality Management System: The manufacturer should have an ISO 13485 certification to demonstrate that the manufacturing process complies with international standards.
2. Safety and Efficacy Documentation: You must provide comprehensive evidence demonstrating the safety and efficacy of the device. This could include:
   • Clinical data, if applicable.
   • Performance testing results.
   • Risk analysis reports.
3. Device Labeling: The product must have labeling in both Arabic and English, which includes detailed information on the device's usage, indications, contraindications, and warnings.

Steps to Apply for Class C Medical Device Registration

1. Pre-registration Requirements

Before submitting the registration application, you need to ensure that:

• The manufacturer complies with SFDA regulations, such as having an ISO 13485 certification.
• The product complies with international standards (e.g., CE mark or FDA approval).
• The device has completed relevant clinical trials or performance tests.
• The device is free of prohibited substances and complies with biocompatibility and electrical safety standards.

2. Register as an Authorized Representative (if applicable)

If you're a foreign manufacturer, you need to appoint an authorized representative in Saudi Arabia. This entity will handle the registration process on your behalf and serve as a liaison with the SFDA.

3. Create an SFDA Account

• Register on the Saudi FDA Medical Device Registration Portal. This is the official platform for submitting all regulatory applications related to medical devices.
• You will need to create a user account, which is required to manage your application and communication with the SFDA.

4. Submit the Registration Application

Prepare and submit the following documents through the SFDA portal:

• Application Form: A detailed form specifying the product and its intended use.
• Certificate of Free Sale: Issued by the competent health authority of the manufacturer’s country.
• ISO 13485 Certificate: Demonstrating the quality management system for the device.
• Risk Management File: Detailing any risks related to the device and how they are mitigated.
• Clinical Data: Evidence of the device’s safety and effectiveness (if applicable).
• Product Labeling: The label and user manual, translated into Arabic and English.
• Test Reports: Reports from biocompatibility tests, electrical safety tests, and performance testing.
• Manufacturing Site Certificate: This shows compliance with Good Manufacturing Practices (GMP).

5. Pay Fees

You will be required to pay the registration fees, which vary based on the classification of the device.

6. SFDA Review and Evaluation

Once your application is submitted, the SFDA will:

• Review your application and documentation.
• Evaluate the safety, performance, and quality of the device.
• Request additional information or clarification if needed.
• In some cases, the SFDA might conduct a site inspection at the manufacturing facility.

7. Obtain Approval

If the SFDA approves the registration, you will receive an official Certificate of Registration for the Class C device. This allows the product to be marketed and sold in Saudi Arabia.

8. Importation and Distribution

Once registered, the device can be imported into Saudi Arabia. An authorized importer needs to handle the logistics and compliance with importation requirements. The device must be marketed in accordance with SFDA regulations.

9. Post-Market Surveillance and Reporting

Once the device is on the market, you must comply with SFDA post-market surveillance requirements. This includes:

• Reporting adverse events and any incidents related to the device.
• Submitting periodic safety updates or technical documentation.
• Responding to any recall or corrective action requests issued by the SFDA.

Additional Considerations

• Product Changes: If there are any significant changes to the device, such as new indications or updates in design, you may need to update your registration.
• Language Requirements: Ensure all labeling, manuals, and supporting documents are in Arabic and English to comply with SFDA regulations.
• Authorized Representative: If you're a foreign manufacturer, it is mandatory to appoint an authorized representative in Saudi Arabia to manage the registration and post-market activities.

Timeline

The registration process for Class C medical devices can take several months. It depends on the complexity of the device, the completeness of your application, and any additional assessments required by the SFDA.

By following these steps and meeting the SFDA’s requirements, you can successfully register your Class C medical device in Saudi Arabia and ensure compliance with their regulations.

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