The process for registering a Class C medical device with the Saudi Food and Drug Authority (SFDA) involves several key steps, requirements, and important considerations. Class C devices are medium-risk products, and their registration requires a comprehensive review to ensure safety, effectiveness, and compliance with Saudi regulations. Below is a detailed breakdown of the process, required materials, and important considerations for the registration of a Class C medical device in Saudi Arabia.

1. Determine Device Classification

Before proceeding with registration, ensure that your medical device is correctly classified as Class C. The classification depends on the device's intended use, the level of risk it poses to patients, and the nature of the medical application. Class C devices typically include surgical instruments, implants, and some in-vitro diagnostic devices.

• Class C Devices: Medium-risk devices that may require clinical data or additional testing to demonstrate safety and effectiveness.

2. Appoint an Authorized Representative (If Applicable)

If the manufacturer is based outside Saudi Arabia, an authorized representative must be appointed in Saudi Arabia. The authorized representative is responsible for handling the registration process and acting as the point of contact between the manufacturer and the SFDA.

• Authorized Representative Requirements:
  • Must be registered with the SFDA.
  • Responsible for compliance, post-market surveillance, and adverse event reporting.
  • Should have experience with regulatory procedures and submission processes.

3. Registration on SFDA Medical Device Portal

• Create an Account: Manufacturers or their authorized representatives need to create an account on the SFDA Medical Device Registration Portal. This portal is used for submitting the device registration application and tracking its progress.
• Login & Profile Setup: Once the account is created, set up the profile with company details and medical device information.

4. Prepare Required Materials (Documentation)

To submit an application for Class C medical device registration, the following documents and materials must be prepared:

a. Application Form

• Complete the SFDA Medical Device Registration Application Form, which requires detailed information about the device, its manufacturer, and its intended use.

b. Certificate of Free Sale (CFS)

• A Certificate of Free Sale is required to show that the device is legally marketed in the country of origin (the manufacturer’s home country).
• The CFS confirms that the device meets the regulatory requirements of the country of origin.

c. ISO 13485 Certification

• ISO 13485 certification is mandatory for manufacturers. This certification demonstrates that the manufacturer has implemented a quality management system that complies with international standards for medical device production.
• It ensures that the device is produced under controlled conditions to meet regulatory requirements.

d. Risk Management File

• The risk management documentation should include:
  • Risk analysis report: Identifying potential risks associated with the device and how they are mitigated.
  • Risk management file: Documentation of the overall process of risk identification, assessment, and control.

e. Clinical Data/Performance Data

• Clinical evidence is required to support the safety and effectiveness of the device. This can include clinical trial data or performance testing results.
• Clinical data may not be needed for all Class C devices, but it is required for devices with innovative technologies, implants, or high-risk procedures.
• Performance testing: If clinical data is not required, performance data or laboratory testing data may be submitted to demonstrate the device's functionality.

f. Product Labeling and Instructions for Use (IFU)

• The device’s labeling must include:

  • Product name, model, and description.
  • Manufacturer details.
  • Intended use, warnings, and precautions.
  • Expiry date and batch number (if applicable).
  • Storage and handling instructions.

• The Instructions for Use (IFU) must be submitted in both Arabic and English. The IFU should clearly explain how to safely use the device, potential risks, and maintenance requirements.

g. Biocompatibility Data (If Applicable)

• For devices that come into direct or indirect contact with the human body (e.g., implants, surgical instruments), biocompatibility testing is required to show that the materials used in the device are safe and do not cause adverse reactions.

h. Electrical Safety and Performance Reports (If Applicable)

• If the device includes electrical components, such as powered medical devices, it must meet international electrical safety standards (e.g., IEC 60601).
• Provide relevant safety and performance testing reports showing compliance with these standards.

i. Manufacturing Site Certificate

• A Manufacturing Site Certificate (or GMP certificate) must be provided to demonstrate that the manufacturing site complies with Good Manufacturing Practices (GMP).
• If the manufacturer is located outside Saudi Arabia, this certificate must be issued by the regulatory authority in the country of origin or by a recognized third-party certifying body.

5. Submit the Registration Application

• Once all the required materials are prepared, submit the registration application through the SFDA Medical Device Registration Portal.
• Upload all supporting documents (e.g., CFS, ISO 13485, clinical data, labeling, etc.).
• Complete the application form with accurate and up-to-date information.

6. Pay Registration Fees

• Pay the applicable registration fees. The fees for Class C devices generally range from SAR 4,000 to SAR 10,000 (approximately USD 1,000 to USD 2,700), depending on the complexity of the device and whether additional testing or inspection is required.
• Additional costs may apply for site inspections, authorized representative services, and post-market surveillance.

7. SFDA Review and Evaluation

• Once the application is submitted, the SFDA will evaluate the submitted documents. This review typically includes:
  • Checking the clinical and performance data.
  • Reviewing the risk management file.
  • Verifying compliance with ISO 13485.
  • Ensuring the device’s manufacturing site complies with GMP.
• If additional information or documentation is needed, the SFDA will contact the applicant for clarification.

8. Manufacturing Site Inspection (If Applicable)

• If the device is manufactured outside Saudi Arabia, the SFDA may require an inspection of the manufacturing site to ensure compliance with Good Manufacturing Practices (GMP).
• The inspection may take 1 to 2 weeks and could add additional time to the registration process.

9. Approval and Registration Certificate

• If the SFDA is satisfied with the application, they will grant registration approval and issue a Certificate of Registration.
• This certificate confirms that the device is cleared for import and sale in Saudi Arabia.
• The registration certificate is usually valid for 5 years, after which the device will need to be re-registered.

10. Post-Market Surveillance

After approval, the manufacturer and authorized representative must comply with the SFDA’s post-market surveillance requirements. This includes:

• Reporting adverse events and product defects.
• Recalling the product if necessary.
• Submitting periodic safety updates to the SFDA.

Important Considerations

1. Regulatory Compliance: Ensure that your device complies with Saudi medical device regulations and international standards (e.g., ISO 13485, IEC 60601) to avoid delays in the approval process.
2. Clinical Data: Be prepared to provide clinical data or performance data, especially for new or high-risk devices.
3. Labeling and IFU in Arabic: Both the device labeling and Instructions for Use (IFU) must be submitted in Arabic and English. Ensure accurate translations to avoid delays.
4. Authorized Representative: Foreign manufacturers must appoint a local authorized representative in Saudi Arabia to manage the registration process and post-market activities.
5. Post-Market Requirements: The SFDA has strict post-market surveillance requirements. Manufacturers should be prepared to handle product recalls, safety reports, and adverse event monitoring.
6. GMP Compliance: If the manufacturing site is overseas, it must meet Good Manufacturing Practices (GMP), and the SFDA may conduct site inspections to verify compliance.

Timeline

The registration process typically takes 3 to 6 months for Class C devices, depending on the complexity of the device, completeness of the application, and any additional requirements like clinical data or inspections.