1. Appoint a Saudi Authorized Representative (AR)

• Non-Saudi manufacturers must appoint a Saudi-based Authorized Representative (AR).
• The AR must hold an SFDA Medical Device Establishment License (MDEL) and act as the liaison between the manufacturer and the SFDA.
• The AR is responsible for the application, communication with SFDA, and post-market obligations.

2. Manufacturer’s Quality Management System (QMS)

• The manufacturer must provide evidence of a Quality Management System (QMS), typically certified to ISO 13485 (Medical Devices – QMS for regulatory purposes).
• ISO 13485 certification ensures the device is manufactured in accordance with international quality standards.

3. Device Classification Confirmation

• Verify that the device is classified as Class C according to the SFDA’s medical device classification rules. This classification helps determine the level of scrutiny and review the device will undergo.

4. Technical Documentation (Technical File)

A comprehensive technical file or dossier must be submitted to the SFDA, including the following:

• Device Description: Detailed description of the device, its intended use, and target population.
• Design and Manufacturing Information: Full information about the device’s design, materials used, and manufacturing process.
• Risk Management File: Evidence of risk analysis and risk control measures, usually in line with ISO 14971 (Medical Device Risk Management).
• Clinical Evaluation: Clinical evidence that the device is safe and performs as intended. This can include clinical studies, performance evaluations, or equivalence studies with similar devices.
• Testing Reports: Results of product safety and performance testing (e.g., biocompatibility, electrical safety, electromagnetic compatibility).

5. Regulatory Approval in Other Jurisdictions

• If the device is already approved or registered in other trusted regulatory markets (such as CE Marking in the EU, FDA clearance in the USA), these approvals should be included in the submission.
• Previous regulatory approvals can expedite the SFDA review process.

6. Declaration of Conformity

• A Declaration of Conformity (DoC) must be submitted, which is a formal statement from the manufacturer declaring that the device complies with relevant standards and regulations.
• The DoC must reference the device’s compliance with international standards such as ISO, IEC, or equivalent.

7. Labeling and Instructions for Use (IFU)

• The device must have compliant labeling and instructions for use (IFU) that meet SFDA regulations.
  • Arabic and English labeling is required.
  • Labels should include all relevant information, such as device description, warnings, precautions, and instructions on safe use.

8. Post-Market Surveillance (PMS) Plan

• A Post-Market Surveillance (PMS) Plan is required for Class C devices. This plan outlines how the manufacturer will monitor the safety and performance of the device after it has been placed on the market.
  • The PMS plan should include procedures for monitoring adverse events, conducting post-market clinical follow-ups (if applicable), and implementing corrective actions if necessary.
  • The AR will be responsible for reporting any adverse events to the SFDA.

9. Clinical Data and Evidence

• Clinical evidence demonstrating the safety and performance of the device is crucial.
  • This can include clinical trials, published literature, or real-world evidence from equivalent devices used in other markets.
  • Devices that have high-risk features or are novel technologies may require more extensive clinical data.

10. Saudi Specific Requirements

• Ensure compliance with Saudi-specific standards and guidelines as outlined by the SFDA, including:
  • Electronic submission through the GHAD system (SFDA’s e-service platform).
  • Adherence to SFDA guidelines for submission, including format and content structure.

11. Pay Registration Fees

• Manufacturers must pay applicable registration fees. Fees vary depending on the class of the device, its complexity, and the level of review required.
• Payment is made through the GHAD system at the time of submission.

12. Testing and Certification

• In some cases, SFDA may require additional testing or certifications for the device, particularly if it involves special technologies or high-risk components.
• Testing may include biocompatibility, electrical safety, or electromagnetic compatibility (EMC) depending on the nature of the device.

13. Post-Market Obligations

• Once registered, manufacturers and ARs must maintain compliance with post-market obligations:
  • Adverse Event Reporting: Report any serious incidents involving the device to the SFDA.
  • Periodic Updates: Regular updates on the safety and effectiveness of the device may be required.
  • Renewal: The marketing authorization typically lasts for 3 to 5 years, after which the registration must be renewed.

14. SFDA Review and Approval

• Once the application is submitted, the SFDA will review the technical documentation and conduct a technical review of the device.
  • Class C devices undergo a moderate-to-high level of scrutiny due to their potential risk.
  • The review may take 6-12 months depending on the completeness of the application and any requests for additional information.
• If approved, the SFDA will issue a Medical Device Marketing Authorization (MDMA), allowing the device to be sold in Saudi Arabia.

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