For D-class medical device registration with the Saudi Food and Drug Authority (SFDA), the technical document requirements primarily focus on demonstrating that the device meets the safety, performance, and quality standards set by the SFDA. While D-class devices are considered low-risk, they still need to provide sufficient documentation to support their compliance with SFDA’s regulations.

Here’s a comprehensive list of the technical documents typically required for D-class medical device registration with the Saudi SFDA:

1. Manufacturer's Information

• Business Registration Certificate: A copy of the manufacturer’s business registration (or equivalent) from the country of origin.
• Manufacturing Facility Information: Details of the manufacturing facility, including the address, contact details, and proof of Good Manufacturing Practices (GMP) or ISO certification (e.g., ISO 13485).
• Authorized Representative Information: If applicable, the Local Authorized Representative (LAR) in Saudi Arabia, along with proof of their registration with the SFDA.

2. Device Description and Classification

• Device Name: Official name and model of the medical device.
• Device Classification: Evidence that the device is classified as a D-class device (low-risk) according to the SFDA guidelines. This includes a description of its intended use and indications.
• Intended Use and Indications for Use: A clear and concise description of the intended purpose of the device and the conditions it is intended to treat, diagnose, or prevent.
• Device Description: A detailed technical description of the device, including materials, design, and mechanism of action. If applicable, provide component lists and principle of operation.

3. Quality Management System (QMS) Documentation

• ISO 13485 Certification: A copy of the ISO 13485 certification or an equivalent quality management system certification. If the device manufacturer is not ISO 13485 certified, they may need to provide alternative evidence of their quality assurance procedures.
• Declaration of Conformity: A formal statement from the manufacturer confirming that the device complies with relevant standards, such as ISO 13485, ISO 14971 (for risk management), and other applicable standards.

4. Labeling and Packaging Information

• Product Label: A copy of the label that will appear on the device packaging, ensuring it complies with SFDA’s labeling guidelines.
  • The label must include:
    • Product name, model, and manufacturer’s details.
    • Intended use, warnings, and contraindications.
    • Storage instructions and expiration date (if applicable).
    • Arabic and English language versions of the label.
• User Manual/Instructions for Use (IFU): A copy of the user manual in Arabic and English, which includes instructions for the device's safe operation, maintenance, and disposal.

5. Certificate of Free Sale (CFS)

• Certificate of Free Sale: A CFS or Free Sale Certificate issued by the relevant national regulatory authority in the country of origin. This certificate confirms that the device is legally sold in the manufacturer's home country and complies with local regulatory standards.
• Export License: If applicable, an export license or equivalent document for international sales.

6. Risk Management Documentation

• Risk Management File: Documentation of the manufacturer’s risk management process for the device, following ISO 14971 (Risk Management for Medical Devices). This includes an evaluation of potential hazards associated with the device and how these are controlled or mitigated.
• Risk Analysis: The risk analysis should identify and address any potential risks related to the device’s use, even if it is classified as a low-risk device.

7. Safety and Performance Data (if applicable)

• Safety and Performance Data: For devices that require testing (such as electrical or mechanical devices), provide test reports to demonstrate the device meets required safety and performance standards. These reports could include:
  • Electrical Safety Testing (e.g., IEC 60601 for electrical medical devices).
  • Biocompatibility Testing (for devices in contact with tissue or bodily fluids).
  • Sterilization and Validation (if the device is sterilized or has a sterile barrier).
  • Mechanical Performance Testing (for devices with moving parts or structural elements).

8. Clinical Evidence (if applicable)

• While D-class devices are low-risk, clinical evidence may be required in certain cases if the device claims to have therapeutic effects or if there is a concern about its safety or efficacy.
• Clinical Evaluation: Provide a clinical evaluation report if clinical trials or studies have been conducted on the device. This may not be necessary for all D-class devices, but if your device is novel or has specific claims, clinical data may be requested.

9. Post-Market Surveillance Plan

• Post-Market Surveillance (PMS) Plan: A plan outlining how the manufacturer will monitor the device’s performance after it has been placed on the market. This includes collecting information on adverse events, complaints, and ensuring the device continues to meet safety and performance standards.
• Periodic Reporting: Some low-risk devices may still be required to submit regular post-market reports.

10. Technical File or Device Master File (DMF)

• Device Master File (DMF): A technical file that includes all the necessary technical and regulatory documents for the device. This file serves as a central record and may include information such as design specifications, risk management plans, labeling, testing, and manufacturing information.

11. Testing and Conformity Reports (if applicable)

• Conformity Assessment: The device must meet all the relevant harmonized standards or international standards (e.g., IEC 60601, ISO 10993, etc.). If the device has been tested in third-party laboratories, provide the test reports that demonstrate the device's conformance to these standards.

Contact Us：

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