The process of registering a Class C medical device with the Saudi Food and Drug Authority (SFDA) involves several key steps to ensure the device complies with the regulatory requirements set by the SFDA. Class C devices are medium-risk devices, requiring a more detailed regulatory review process than low-risk devices (Class A and B) but less stringent than high-risk devices (Class D).

Here is a breakdown of the steps and process involved in registering a Class C medical device with the SFDA:

1. Determine the Classification of the Device

Before beginning the registration process, you need to determine that the device is indeed classified as Class C. Class C devices are typically medium-risk products, such as surgical instruments, implants, and certain in-vitro diagnostic devices.

Class C devices require a more comprehensive assessment, including clinical data, risk management, and performance testing.

2. Appoint an Authorized Representative in Saudi Arabia (if applicable)

If the manufacturer is based outside Saudi Arabia, it is mandatory to appoint an Authorized Representative in Saudi Arabia. This representative will handle the registration process and act as the local liaison with the SFDA. The authorized representative is responsible for ensuring that all regulatory requirements are met.

3. Register on the SFDA Medical Device Registration Portal

• Create an Account: Manufacturers or their authorized representatives need to register on the SFDA’s official Medical Device Registration Portal. This portal is the primary platform for submitting applications and documents for medical device registration.
• Account Setup: After creating the account, the authorized representative or local distributor will need to complete the profile with all required details, including the company's information, device type, and product details.

4. Prepare Required Documentation

You need to prepare and submit the following documents for the Class C device registration:

1. Application Form: Complete the official SFDA medical device registration application form.

2. Certificate of Free Sale: This certificate is issued by the regulatory authority in the country of origin, indicating that the device is freely sold in that country and complies with all regulatory requirements.

3. ISO 13485 Certification: The manufacturer must provide a valid ISO 13485 certification. This certification demonstrates that the manufacturer’s quality management system complies with international standards for medical device production.

4. Manufacturing Site Certificate: A certificate from the manufacturer showing that the production site complies with Good Manufacturing Practices (GMP).

5. Risk Management Documentation: This includes a risk analysis and a risk management file that shows how potential risks related to the device are identified and mitigated.

6. Clinical Data/Performance Data: Provide clinical evidence (if applicable) or performance testing data demonstrating the safety and effectiveness of the device. This is especially required for new devices or those with innovative technologies.

7. Product Labeling and Instructions for Use: Labels and user manuals must be submitted in both Arabic and English. This includes clear information on how to use the device, its indications, contraindications, warnings, and maintenance instructions.

8. Biocompatibility Data: For devices that come into contact with the human body, biocompatibility testing results must be provided to ensure the device is safe for use.

9. Electrical Safety and Performance Reports (if applicable): If the device includes electrical components, it must meet electrical safety standards, and reports from the relevant tests must be submitted.

5. Submit the Application via the SFDA Portal

Once all required documentation is ready, the application can be submitted through the SFDA portal:

• Upload all the prepared documents.
• Complete the required fields in the application form.
• Pay the registration fee (fees may vary based on the type of device and classification).

6. SFDA Review and Evaluation

After submission, the SFDA will conduct a thorough review of the application. During this process, the SFDA will assess:

• The safety, effectiveness, and quality of the device.
• The compliance of the device with Saudi regulations.
• Any additional clinical data or performance testing needed.
• Whether the device’s manufacturing processes meet international standards.

If the SFDA requires further information or clarification, they will notify the applicant and request the necessary documents.

7. Site Inspection (If Applicable)

The SFDA may request an inspection of the manufacturing facility if:

• The manufacturing site is located outside Saudi Arabia.
• The SFDA requires confirmation that the site complies with Good Manufacturing Practices (GMP).

This step is particularly important for Class C devices as they carry a moderate risk, and the SFDA may want to ensure proper controls are in place to ensure safety and quality.

8. Receive Approval from the SFDA

If the device meets all regulatory requirements, the SFDA will issue a Certificate of Registration for the Class C device. This allows the device to be legally marketed and sold in Saudi Arabia.

• The Certificate of Registration includes the registration number and expiration date (usually valid for 5 years).

9. Post-Market Surveillance and Vigilance

After the device is registered and marketed, the manufacturer and authorized representative must comply with SFDA’s post-market surveillance requirements, which include:

• Reporting adverse events or incidents related to the device.
• Recalls or corrective actions if issues are identified post-market.
• Submitting periodic safety updates or technical documentation to the SFDA.

10. Importation of the Device

Once the device is registered, it can be imported into Saudi Arabia for commercial distribution. Importers must also comply with SFDA regulations for medical device importation and may need to obtain an importation license.

Timeline for Registration

The registration process for Class C devices typically takes several months. Factors influencing the timeline include:

• The complexity of the device.
• The completeness of the submitted documentation.
• Whether the SFDA requires additional testing or site inspections.

Key Points to Remember

• ISO 13485 certification is required for the manufacturing process.
• The device should have supporting clinical data, performance data, and risk management documentation.
• All documents must be provided in Arabic and English.
• An authorized representative is required if the manufacturer is not based in Saudi Arabia.
• Class C devices must comply with SFDA regulations to ensure patient safety.

By following these steps, you can successfully register a Class C medical device with the Saudi SFDA.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn