To apply for Class C medical device registration with the Saudi Food and Drug Authority (SFDA), certain conditions must be met to ensure compliance with regulatory standards. These conditions are focused on demonstrating that the device is safe, effective, and manufactured according to international quality standards. Below are the key conditions and requirements that must be fulfilled:

Conditions to Apply for Class C Medical Device Registration

1. Device Classification Verification

• Class C Classification: First, confirm that the device qualifies as Class C according to SFDA's medical device classification criteria. Class C devices are typically considered medium-risk devices that require substantial documentation of their safety and efficacy. They may involve invasive procedures, implants, or diagnostic tests that could pose moderate risks to patients if misused.
• Risk Profile: Devices that are typically considered for Class C include:
  • Invasive devices (e.g., implants, surgical instruments).
  • Devices with significant safety concerns (e.g., diagnostic equipment requiring high accuracy).
  • Devices requiring clinical data to demonstrate safety and efficacy.

2. Authorized Representative (For Foreign Manufacturers)

• Local Authorized Representative: If the device manufacturer is located outside Saudi Arabia, an authorized representative based in Saudi Arabia is required. The authorized representative will be responsible for submitting the registration application, communicating with the SFDA, and ensuring compliance with post-market surveillance requirements.
• Appointment and Documentation: The authorized representative must be legally registered with the SFDA and have a valid contract with the manufacturer.

3. Compliance with SFDA Regulations and International Standards

• Quality Management System: The manufacturer must have an ISO 13485:2016 certified quality management system. This certification ensures that the manufacturer complies with international standards for medical device production, including Good Manufacturing Practices (GMP).
• Manufacturing Site: The manufacturing facility must adhere to GMP, and if it is located outside Saudi Arabia, the SFDA may require an inspection of the site to confirm compliance.

4. Clinical Data (If Applicable)

• Clinical Evidence: Depending on the device type, clinical or performance data may be required to demonstrate its safety and effectiveness. This is especially important for Class C devices, which typically pose moderate risks.
• Clinical Trials: For high-risk devices, data from clinical trials conducted in accordance with recognized guidelines may be needed.
• Equivalence Data: If the device is similar to a previously approved device, equivalence data (e.g., comparisons with predicate devices) may be sufficient to demonstrate safety and performance.

5. Documentation of Risk Management

• Risk Management File: A comprehensive risk management file is essential, outlining the device’s risk assessment and the steps taken to mitigate identified risks. The file must adhere to the ISO 14971 standard (Risk Management for Medical Devices).
• Risk Control Measures: The file should demonstrate how potential hazards related to the device are identified, analyzed, and controlled, ensuring patient safety and device effectiveness.

6. Device Labeling and Instructions for Use (IFU)

• Accurate and Compliant Labeling: The device's labeling and packaging must meet SFDA requirements. This includes:
  • The device name, model, and description.
  • Manufacturer details, including the address and contact information.
  • Intended use, contraindications, warnings, and precautions.
  • Storage conditions, handling instructions, and special use requirements.
• Instructions for Use (IFU): The IFU must provide clear, concise instructions in both Arabic and English. The IFU should include:
  • How to use the device safely.
  • Maintenance, cleaning, and troubleshooting instructions.
  • Warnings and cautions regarding potential risks.
  • Indications for use, contraindications, and any special instructions.
• SFDA requires that labeling and IFUs be translated accurately into Arabic to ensure that they are comprehensible to healthcare professionals and patients.

7. Free Sale Certificate (CFS)

• Certificate of Free Sale (CFS): A CFS must be provided to prove that the medical device is legally sold in the country of origin or other markets. The CFS confirms that the device meets the regulatory requirements of the country where it is marketed.
  • The CFS must be issued by the competent regulatory authority of the country of origin.
  • For devices sold in multiple countries, provide CFS from each country if required.

8. Compliance with Other International Standards

• Safety Standards: For certain types of devices, such as electrical devices or implants, compliance with specific international safety standards (e.g., IEC 60601 for electrical safety or ISO 10993 for biocompatibility) may be required.
• Biocompatibility Testing: If the device comes into direct or indirect contact with the human body (e.g., implants, surgical instruments), you will need to provide biocompatibility testing data in accordance with ISO 10993 standards.
• Electrical Safety and EMC Testing: If the device is electrical, it should comply with the relevant electrical safety standards (e.g., IEC 60601) and electromagnetic compatibility (EMC) standards.

9. No Outstanding Regulatory Issues

• Clear Regulatory History: The device manufacturer should have no outstanding regulatory issues in any other country. If the device has been recalled or faced regulatory scrutiny, this must be disclosed to the SFDA.
• Post-Market Surveillance Compliance: Manufacturers and authorized representatives must be able to demonstrate an understanding of post-market surveillance obligations, including adverse event reporting and conducting device recalls if necessary.

10. Good Manufacturing Practice (GMP) Compliance

• Manufacturing Site Inspection (If Applicable): The SFDA may conduct an inspection of the manufacturing facility (if the device is manufactured outside Saudi Arabia) to confirm compliance with Good Manufacturing Practices (GMP). If the manufacturing site is in Saudi Arabia, the facility must be registered with the SFDA.

11. Registration Fee Payment

• Payment of Registration Fees: The application must be accompanied by the payment of the appropriate registration fee. The fee amount is typically based on the device classification and the complexity of the application process.

Additional Considerations for Class C Medical Device Registration

1. SFDA Communication: Be prepared to communicate with the SFDA during the application process. If the SFDA requires additional information or clarifications, ensure prompt and thorough responses.
2. Post-Market Obligations: Once registered, manufacturers must comply with post-market surveillance requirements, including reporting adverse events, conducting recalls, and maintaining up-to-date records.
3. Local Representation: Ensure that the authorized representative is well-versed in SFDA regulations and can effectively handle any regulatory requests or issues that arise during the registration process.

Summary of Key Conditions

To apply for Class C medical device registration with the SFDA, the following conditions must be met:

1. The device must be correctly classified as Class C.
2. The manufacturer must comply with ISO 13485 standards.
3. Clinical or performance data may be required to demonstrate safety and efficacy.
4. A risk management file should be in place.
5. The device labeling and IFU must meet SFDA requirements in both Arabic and English.
6. A Certificate of Free Sale (CFS) must be provided.
7. The manufacturer must adhere to relevant international safety standards (e.g., ISO 10993, IEC 60601).
8. An authorized representative in Saudi Arabia must be appointed if the manufacturer is outside the country.
9. Compliance with Good Manufacturing Practices (GMP) is essential.
10. Registration fees must be paid.

By meeting these conditions, you can successfully apply for Class C medical device registration with the Saudi SFDA.

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