Required Materials for D-Class Medical Device SFDA Registration and How to Prepare the Application Documents

When applying for D-class medical device registration with the Saudi Food and Drug Authority (SFDA), the documentation requirements are extensive, as D-class devices are high-risk and require a thorough evaluation. Below is a detailed list of the required materials for registration and guidance on how to prepare the application documents:

1. Required Materials for D-Class Medical Device SFDA Registration

Here are the essential materials and documents required for D-class medical device registration with the SFDA:

1.1. Device Information

• Device Name: The name and model of the medical device.
• Device Classification: Confirm that the device is classified as D-class, which is for high-risk medical devices.
• Intended Use: A clear description of the device's intended medical purpose and how it will be used (e.g., implantable, life-supporting).
• Device Description: Detailed specifications, components, and features of the device.
• Risk Classification: Include the rationale for the device’s risk classification (D-class), based on SFDA criteria or international classification standards (e.g., MDR, FDA).

1.2. Manufacturer Information

• Manufacturer Details: Full contact details of the manufacturer, including the name, address, and contact information.
• Manufacturing Facility: Details about the manufacturing site(s), including location and quality management practices.
• Good Manufacturing Practices (GMP): Evidence that the manufacturer follows Good Manufacturing Practices (GMP), including inspection reports, certifications, and audit results.

1.3. Clinical Evidence

• Clinical Evaluation Report: Detailed clinical data or evaluation of the device, demonstrating that it is safe and effective for its intended use.
  • Clinical Trials: If applicable, provide evidence from clinical trials that support the device's safety and performance. This includes the trial design, methodology, results, and any post-market follow-up data.
  • Post-Market Surveillance Data: If the device is already marketed in other regions, provide data from post-market surveillance (PMS) or post-market clinical follow-up (PMCF) to demonstrate ongoing safety and performance.
• Clinical Studies Summary: Summary of clinical study reports or published peer-reviewed clinical data.

1.4. Risk Management Documentation

• Risk Management File: A file demonstrating compliance with ISO 14971 (Risk Management for Medical Devices), which includes:
  • Risk Assessment: Identification and evaluation of all potential risks associated with the device.
  • Risk Control Measures: Description of the measures taken to mitigate these risks.
  • Residual Risks: Identification and explanation of any remaining risks after mitigation measures are applied.

1.5. Conformity Assessment

• Conformity Declaration: A declaration stating that the device complies with applicable regulatory requirements.
  • CE Marking (if applicable): If the device has CE marking, include a copy of the CE certificate and the assessment report.
  • FDA Approval (if applicable): For devices already approved by the FDA, provide copies of FDA approval letters or certificates.
  • Other International Certifications: If the device has certifications from other jurisdictions (e.g., Canada, Australia), include copies of these certificates.

1.6. Quality Management System (QMS)

• ISO 13485 Certification: A copy of the ISO 13485 certification, which demonstrates that the manufacturer follows an internationally recognized quality management system for medical devices.
• Quality Control Procedures: Documentation detailing the manufacturing processes and quality control measures in place to ensure consistent device quality.

1.7. Device Labeling and Packaging Information

• Labeling: Provide the labeling of the device, including:
  • Product name, model, and serial number.
  • Manufacturer's name and address.
  • Intended use and warnings.
  • Instructions for use (IFU), including handling and storage instructions.
• Packaging: Include packaging specifications, if relevant, for the safe transport and storage of the device.

1.8. Device Testing Data

• Pre-Clinical Testing: If applicable, include pre-clinical testing data that shows the device meets performance standards (e.g., biocompatibility, electrical safety).
• Safety and Efficacy Testing: Data that confirms the device meets all safety and performance requirements as outlined by regulatory standards.

1.9. Manufacturing Documents

• Manufacturing Procedures: Detailed manufacturing procedures, including materials used and production processes.
• Sterilization Processes: If the device is sterilized, include information on the sterilization methods and validation of these processes.

1.10. Declaration of Conformity

• A signed statement by the manufacturer declaring that the device complies with all relevant SFDA regulations and standards.

2. How to Prepare the Application Documents

To ensure the SFDA registration application is complete and meets regulatory requirements, the following steps will help you prepare the necessary documents:

2.1. Document Organization and Preparation

• Organize Documents: Arrange all documents logically and clearly. Use a checklist to ensure you include all the required materials.
• Document Translation: If any documents are not in Arabic, ensure they are professionally translated. SFDA may require key documents in Arabic, such as the device description, labeling, and instructions for use.

2.2. Prepare Clinical Evidence

• Clinical Data Collection: If your device is already on the market in other countries (e.g., Europe or the U.S.), gather clinical trial data or post-market surveillance reports. For new devices, you may need to conduct clinical trials.
• Summarize Clinical Studies: If clinical trials are extensive, provide a summary of key clinical findings, including safety and efficacy results.

2.3. Risk Management and Conformity

• Complete Risk Management Documentation: Ensure the risk management file is complete and follows ISO 14971 standards, detailing how potential risks are identified, evaluated, and mitigated.
• Gather Conformity Documentation: If your device has received CE marking or FDA approval, ensure that you include copies of these certificates. These documents can greatly streamline the SFDA’s review process.

2.4. Quality Management System (QMS) Documentation

• ISO 13485 Certificate: Provide a copy of the ISO 13485 certification. If your company has a QMS, ensure it aligns with SFDA requirements, and that all processes meet international standards.
• Quality Control and Manufacturing Documentation: Ensure that you have detailed manufacturing documentation that outlines processes and quality checks.

2.5. Device Labeling

• Prepare Clear and Accurate Labeling: Device labeling is critical. Ensure all required information (e.g., product name, manufacturer, intended use, warnings) is included and formatted according to SFDA guidelines.
• Instructions for Use (IFU): Make sure that IFU are clear and easy to follow, as this is a vital part of the registration process.

2.6. Submit Through Mysfda Portal

• Create an Account: First, you must create an account on the Mysfda portal (the official SFDA portal for medical device registration).
• Complete the Application: After logging into Mysfda, fill out the online application form, including device information, manufacturer details, and other relevant data.
• Upload Documents: Upload all the prepared documents directly to the portal. Ensure all documents are in the correct format (PDF, Word, etc.) and comply with SFDA guidelines.
• Pay Fees: After submitting the documents, you will need to pay the registration fee through the portal.

2.7. Follow-up and Address Queries

• Track Application Status: Once your application is submitted, monitor the status via Mysfda. The SFDA may request additional information or clarifications.
• Respond Promptly: If the SFDA requests further documentation or clarifications, respond as quickly and thoroughly as possible to avoid delays.

3. Precautions to Take While Preparing the Application

• Accuracy and Completeness: Ensure that all required information is accurate and complete. Missing or incorrect documents can delay the approval process.
• Comply with SFDA Guidelines: Review the SFDA’s latest guidance documents for medical device registration and ensure your application aligns with their specific requirements.
• Translation: Ensure that documents are professionally translated into Arabic where required. Inaccurate or incomplete translations may cause delays or rejections.
• Prepare for Inspections: D-class devices may require an on-site inspection by the SFDA. Make sure that your manufacturing facility is ready for an inspection, with all necessary documentation readily available.

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