For RZN certification of Class 2b medical devices in Russia, the technical document requirements are comprehensive and ensure that the device meets all necessary safety, performance, and quality standards. Here’s a detailed list of the technical document requirements:

1. Device Description

• General Information: A detailed description of the medical device, including its intended use, design, functionality, and how it achieves its intended purpose.
• Specifications: Technical specifications, including dimensions, materials used, and operational principles.
• Components and Accessories: Details about any components or accessories that are part of the device or are required for its operation.

2. Design and Manufa

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cturing Information

• Design Documentation: Information on the design process, including design control measures and changes made during development.
• Manufacturing Processes: Descriptions of the manufacturing processes and techniques used, including controls and procedures to ensure product quality.
• Quality Control: Detailed procedures for quality control and assurance, including testing and inspection methods.

3. Performance Testing Data

• Preclinical Testing: Results from laboratory tests and studies demonstrating the device’s safety and performance before clinical use.
• Clinical Testing Data: If applicable, clinical trial results or studies that validate the device's safety and effectiveness. This should include:
  • Study Design: Information on the clinical trial design, methodology, and objectives.
  • Results: Data from clinical trials showing the device’s performance and any adverse events encountered.
  • Conclusion: Summary of the clinical data, including conclusions on the device’s safety and effectiveness.

4. Risk Management

• Risk Analysis: A risk analysis report identifying potential risks associated with the device and measures taken to mitigate these risks.
• Risk Management Plan: Documented procedures for ongoing risk management and control throughout the product lifecycle.

5. Quality Management System (QMS) Documentation

• ISO 13485 Certification: Proof of compliance with ISO 13485 or an equivalent quality management system standard.
• QMS Procedures: Detailed documentation of quality management procedures, including:
  • Design Control: Procedures for design and development control.
  • Supplier Management: Processes for managing suppliers and ensuring the quality of supplied materials.
  • Non-Conformance and Corrective Actions: Procedures for handling non-conformities and implementing corrective actions.
  • Internal Audits: Records of internal audits and their findings.

6. Labeling and Instructions for Use

• Device Labeling: Copies of labels that will appear on the device packaging and device itself. Labels must include:
  • Device Name: The name and model of the device.
  • Manufacturer Information: Manufacturer’s name, address, and contact information.
  • Intended Use: A clear description of the intended use and indications for the device.
  • Warnings and Precautions: Safety warnings, precautions, and contraindications.
• Instructions for Use (IFU): Detailed instructions on how to use the device, including:
  • Setup and Operation: Steps for setting up and operating the device.
  • Maintenance and Care: Instructions for maintaining and caring for the device.
  • Troubleshooting: Common issues and troubleshooting steps.
  • Disposal: Guidance on the proper disposal of the device.

7. International Certifications

• Existing Certifications: Copies of any existing international certifications such as CE mark, FDA approval, or other relevant certifications. These can help demonstrate that the device meets international standards and facilitate the RZN certification process.

8. Technical File Preparation

• Organized Documentation: Ensure that all documents are well-organized, clearly labeled, and compiled in a manner that facilitates easy review by Roszdravnadzor.
• Translations: Ensure that all documents required by Roszdravnadzor are translated into Russian by a certified translator.

Additional Considerations

• Updates and Revisions: Keep documentation up-to-date with any changes in design, manufacturing processes, or regulatory requirements.
• Consultation with Experts: Consider working with regulatory experts or consultants who have experience with Russian medical device regulations to ensure that all technical document requirements are met.

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