To process the registration of a Class C medical device with the Saudi Food and Drug Authority (SFDA), the following requirements must be met. Class C devices are considered medium-risk, so they require a more detailed review process compared to low-risk devices (Class A and B) but are less stringent than high-risk devices (Class D).

1. Regulatory Requirements and Classification

Before proceeding with registration, ensure that the device is correctly classified as Class C. This classification depends on factors such as the device's risk, intended use, and the nature of the medical application. Class C devices include surgical instruments, implants, and certain diagnostic devices.

2. Authorized Representative

If the manufacturer is located outside Saudi Arabia, an authorized representative in Saudi Arabia must be appointed. The representative will:

• Act as the liaison between the manufacturer and the SFDA.
• Submit the application and handle all communication with the SFDA on behalf of the manufacturer.

The authorized representative must be registered with the SFDA and maintain responsibility for post-market activities.

3. Registration in the SFDA Portal

To process the registration, you must first create an account in the SFDA’s Medical Device Registration Portal. The portal is used for submitting applications and tracking the status of the registration.

4. Required Documents for Registration

The following documentation is required to register a Class C medical device with the SFDA:

a. Application Form

• Complete the official SFDA Medical Device Registration Application Form.
• The form will require details about the manufacturer, device, intended use, and other relevant information.

b. Certificate of Free Sale

• The Certificate of Free Sale (CFS) is issued by the regulatory authority in the country of manufacture, confirming that the device is legally sold and marketed in that country.
• The CFS should be up-to-date and reflect the status of the device in the country of origin.

c. ISO 13485 Certification

• The manufacturer must hold a valid ISO 13485 certificate, which indicates compliance with international standards for medical device quality management systems.
• This certification is mandatory for manufacturers to demonstrate their adherence to Good Manufacturing Practices (GMP).

d. Risk Management File

• A risk management file must be submitted, demonstrating that all potential risks related to the device have been evaluated and controlled.
• This includes a risk analysis report, identifying potential hazards and mitigating actions taken during the design and manufacturing process.

e. Clinical and Performance Data

• Clinical data (if applicable) should be provided to support the safety and effectiveness of the device.
• If clinical trials were conducted, include the trial results, methodology, and data.
• Performance data may also be necessary to show that the device performs as intended under normal conditions of use.

f. Product Labeling and Instructions for Use

• The labeling for the device must include essential information such as:
  • Device name and model.
  • Intended use.
  • Warnings and precautions.
  • Manufacturer details.
  • Storage and handling instructions.
  • Batch/lot number (if applicable).
  • Expiry date (if applicable).
• Instructions for Use (IFU) must be provided in both Arabic and English.

g. Biocompatibility Data

• For devices that come into direct or indirect contact with patients (e.g., implants, surgical instruments), biocompatibility testing data must be submitted.
• This testing ensures that the materials used in the device do not cause adverse reactions when used in medical applications.

h. Electrical Safety (if applicable)

• If the device includes electrical components, it must comply with international electrical safety standards (e.g., IEC 60601 for medical electrical equipment).
• Provide test reports and certificates showing compliance with these standards.

i. Manufacturing Site Certificate

• A manufacturing site certificate is required to show that the manufacturing facility complies with Good Manufacturing Practices (GMP).
• This certificate may be issued by the regulatory authority in the country of origin or a third-party certifying body.

5. Device Classification and Technical Documentation

• Ensure that the device is correctly classified according to Saudi regulations. Class C devices should meet the SFDA medical device classification criteria.
• The technical documentation should include a detailed description of the device, its components, functionality, and intended use.

6. Submit the Application and Pay Fees

• After gathering all the required documents, submit the registration application through the SFDA Medical Device Registration Portal.
• Pay the relevant registration fees. The fees vary based on the classification and type of device.

7. SFDA Review and Evaluation

• The SFDA will assess the submitted application and all supporting documents.
• The evaluation process may involve:
  • Reviewing clinical and performance data.
  • Assessing quality management systems (ISO 13485 compliance).
  • Reviewing the risk management file.

If the SFDA requires additional information or documentation, they will request clarification or supplementary data from the manufacturer or the authorized representative.

8. Inspection (if applicable)

• The SFDA may request a site inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP) and other relevant standards.
• The SFDA may also inspect the production process and assess the device's manufacturing conditions to ensure the device's safety and quality.

9. Receive Registration Approval

If the SFDA deems the device compliant with all regulatory requirements, you will receive an SFDA Certificate of Registration. This certificate grants the device market approval in Saudi Arabia.

• The registration certificate is usually valid for 5 years.
• After obtaining approval, the device can be imported, distributed, and sold in Saudi Arabia.

10. Post-Market Surveillance and Vigilance

• Post-market surveillance is a critical component of the regulatory framework. The manufacturer and authorized representative must monitor the device's performance after it has been placed on the market.
• Any adverse events or device malfunctions must be reported to the SFDA in accordance with their vigilance and reporting guidelines.
• Periodic updates on the device's safety, efficacy, and performance may be required by the SFDA.

Additional Requirements:

• Periodic Safety Updates: You may be required to submit regular safety updates or new clinical data post-market.
• Adverse Event Reporting: Report any adverse events or device recalls promptly to the SFDA.

Timeline

The entire registration process for a Class C medical device can take several months (usually 3-6 months or more), depending on the complexity of the device, completeness of the documentation, and any additional requirements such as clinical data or site inspections.

Conclusion

To successfully register a Class C medical device with the SFDA, you must meet the regulatory requirements, prepare comprehensive documentation, and follow the SFDA’s submission process. Properly managing the application and providing all necessary information will facilitate a smoother registration process and ensure compliance with Saudi regulations.

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