The technical file requirements for NMPA (National Medical Products Administration) registration of medical devices in China are comprehensive and must be carefully prepared to demonstrate the safety, efficacy, and quality of the device. Here’s an overview of the key components typically included in the technical file:

Essential Components of the Technical File:

1. Device Description and Specifications:

   • Device Identification: Unique device identifier (UDI), model numbers, and version details.
   • Intended Use: Clear description of the device’s intended purpose and indications for use.
   • Principle of Operation: Description of how the device functions and its mechanism of action.
   • Technical Specifications: Detailed specifications including dimensions, materials used, and technical parameters.

2. Design and Development Information:

   • Design Rationale: Explanation of design choices and considerations, including user needs and intended clinical benefits.
   • Engineering Drawings: Detailed drawings or schematics illustrating the device design and construction.

3. Quality Management System (QMS) Documentation:

   • ISO 13485 Certification: Evidence of compliance with ISO 13485 or an equivalent quality management system standard.
   • QMS Documentation: Documentation outlining procedures and processes related to design controls, risk management, production, and process controls.

4. Clinical Data and Evaluations:

   • Clinical Evaluation Report (CER): For Class II and III devices, a systematic assessment of clinical data to evaluate the device’s safety and performance.
   • Clinical Trial Data: If clinical trials were conducted, include study protocols, results, and conclusions.

5. Testing Reports:

   • Performance Testing: Results of testing demonstrating that the device meets specified performance criteria under anticipated conditions of use.
   • Biocompatibility Testing: Reports indicating the device’s biocompatibility as per ISO 10993 standards.
   • Electrical Safety Testing: Compliance with relevant electrical safety standards (e.g., IEC 60601 series).

6. Risk Management Documentation:

   • Risk Management Plan: Identification of potential hazards associated with the device and description of risk mitigation measures throughout the device lifecycle.

7. Labeling and Instructions for Use (IFU):

   • Labeling: Copies of device labels and packaging, including translations into Chinese. Labels must include device identification, usage instructions, warnings, and precautions.
   • Instructions for Use (IFU): Translated into Chinese, providing clear guidance on device operation, storage, maintenance, and troubleshooting.

8. Manufacturing Information:

   • Manufacturing Processes: Detailed description of manufacturing processes, facilities, and controls.
   • GMP Compliance: Evidence of compliance with Good Manufacturing Practice (GMP) regulations or equivalent standards.

9. Other Documentation:

   • Authorization Letter: If using a local agent or representative in China, include an authorization letter empowering them to act on your behalf for NMPA registration purposes.

Preparation Tips:

• Start Early: Begin preparing the technical file well in advance to ensure all required documentation is complete and accurate.

• Document Translation: Ensure all documents are translated into Chinese by professional translators to comply with NMPA requirements.

• Review and Compliance: Review each document to ensure it meets NMPA regulations and guidelines. Address any gaps or inconsistencies before submission.

• Consult Regulatory Experts: Work with regulatory consultants or local agents experienced in NMPA registration to navigate requirements effectively.

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