The technical file requirements for NMPA (National Medical Products Administration) registration of medical devices in China are comprehensive and must demonstrate the safety, efficacy, and quality of the device. These requirements vary depending on the classification and risk level of the device, but generally include the following components:

1. Device Description and Specifications:

   • Detailed description of the medical device, including its intended use, indications, and technical specifications such as dimensions, materials, and components.

2. Design and Manufacturing Information:

   • Documentation outlining the device’s design features, engineering drawings, manufacturing processes, and assembly procedures. Include information on the manufacturing site and processes.

3. Risk Management Documentation:

   • Comprehensive risk assessment and risk management documentation, identifying potential risks associated with the device and outlining measures taken to mitigate these risks throughout the device lifecycle.

4. Testing and Validation Reports:

   • Provide detailed testing and validation data to demonstrate compliance with relevant standards and specifications. This may include:
     • Performance testing (e.g., electrical safety, mechanical testing).
     • Biocompatibility testing (to assess biological safety).
     • Sterility testing (if applicable).
     • Shelf-life and stability testing (if applicable).

5. Clinical Evaluation Data (if applicable):

   • For higher-risk devices, provide clinical evaluation data to support the safety and efficacy of the device. This may involve clinical trial reports or literature-based evidence demonstrating clinical performance.

6. Labeling and Instructions for Use (IFU):

   • Ensure that labeling and IFU are provided in Chinese. Include all required information regarding device identification, usage instructions, warnings, precautions, and storage conditions.

7. Quality Management System (QMS) Documentation:

   • Evidence of compliance with ISO 13485 or equivalent quality management standards. Include documents such as QMS manuals, procedures, records of audits, and corrective actions.

8. Declaration of Conformity:

   • A statement affirming that the medical device conforms to relevant Chinese regulations, standards, and technical requirements. This declaration should be signed by an authorized representative of the manufacturer.

Additional Considerations:

• Language Requirements: All technical documentation, including testing reports, must be translated into Chinese. Ensure translations are accurate and comprehensive.

• Compliance with Standards: Verify that all documentation and testing results comply with current Chinese regulatory standards and guidelines specified by the NMPA.

• Organizational Structure and Responsibilities: Outline the organizational structure of the manufacturer, including roles and responsibilities related to regulatory compliance, quality assurance, and post-market surveillance.

• Modification and Change Control: Provide procedures for managing modifications and changes to the device design, manufacturing processes, labeling, and other relevant aspects after obtaining registration.

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