In Saudi Arabia, Class C medical device SFDA registration refers to the regulatory process and requirements set by the Saudi Food and Drug Authority (SFDA) for medical devices classified as Class C.

Understanding Class C Medical Devices

1. Classification:

   • Class C: Medical devices are categorized into different classes based on the risk they pose to patients and users. Class C medical devices are considered to have a higher risk compared to Class A and Class B devices but lower than Class D devices. They typically include devices that are used in critical applications or that have significant risks if they fail or malfunction.

2. Regulatory Requirements:

   • Higher Standards: Class C devices must meet stringent safety, effectiveness, and quality standards due to their potential impact on patient health.
   • Detailed Documentation: The registration process for Class C devices requires comprehensive technical documentation, including clinical data, risk management plans, and evidence of compliance with international standards.

SFDA Registration Process for Class C Devices

1. Objective:

   • Approval: The registration process aims to ensure that Class C medical devices meet the necessary safety and effectiveness standards before they are allowed to be marketed and used in Saudi Arabia.

2. Requirements:

   • Technical Documentation: Detailed technical file including device description, design and manufacturing information, risk management, clinical evaluation, and testing reports.
   • Quality Management System: Proof of compliance with ISO 13485 or equivalent standards.
   • Labeling: Labeling and Instructions for Use (IFU) in Arabic and English.

3. Application Process:

   • Submission: Application is submitted through the SFDA’s GHAD (Generic Health and Drug) portal.
   • Review: SFDA conducts a thorough review of the submitted documents and may request additional information.
   • Approval: Upon satisfactory review, SFDA grants registration, allowing the device to be marketed in Saudi Arabia.

4. Post-Market Requirements:

   • Surveillance: Ongoing monitoring of device performance and safety once it is on the market.
   • Reporting: Obligations to report adverse events and maintain compliance with regulatory conditions.

Key Points to Note

• Risk Management: Class C devices must demonstrate robust risk management to address potential hazards associated with their use.
• Clinical Evidence: Clinical data is often required to support the device’s safety and effectiveness.
• Regulatory Compliance: Compliance with both SFDA regulations and international standards is crucial.

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