To prepare application files for NMPA (National Medical Products Administration) registration of Class III medical devices in China, you need to compile a comprehensive set of documents that demonstrate compliance with Chinese regulatory requirements. Here are the key documents required and how to prepare them:

Required Documents:

1. Device Technical Documentation:

   • Device Description and Specifications: Detailed description of the device, its intended use, components, and materials used.
   • Design Drawings and Diagrams: Technical drawings illustrating the device's structure, dimensions, and operation.
   • Manufacturing Processes: Detailed documentation of manufacturing processes, including quality control procedures and documentation of compliance (e.g., GMP).
   • Risk Analysis: Comprehensive risk analysis according to ISO 14971, detailing identified hazards, risk controls, and justification for risk management decisions.
   • Instructions for Use and Labeling: Clear and concise instructions for use (IFU) in Chinese, including labeling requirements compliant with Chinese regulations.

2. Quality Management System (QMS) Documentation:

   • ISO 13485 Certification: Certificate demonstrating compliance with ISO 13485 or equivalent QMS standard recognized by the NMPA.
   • QMS Documentation: Detailed documentation of your Quality Management System, including procedures, work instructions, and records related to device manufacture and quality control.

3. Clinical Data (if applicable):

   • Clinical Evaluation Report: Comprehensive report evaluating clinical data to demonstrate device safety and performance. Include summaries of clinical trials conducted in China or relevant clinical data from other countries.
   • Clinical Trial Reports: Detailed reports from clinical trials conducted to support the safety and efficacy of the device, if applicable.

4. Testing Reports (if required):

   • Testing Data: Reports from testing conducted to demonstrate compliance with relevant Chinese standards. Testing should be performed by accredited Chinese laboratories.

5. Authorization and Declaration Letters:

   • Authorization Letter for Local Agent: Letter authorizing your local agent or representative in China to act on your behalf for NMPA registration.
   • Manufacturer’s Authorization Letter: If applicable, a letter authorizing your local agent to submit the application on behalf of the manufacturer.

6. Other Documents:

   • Device Master File (DMF): If applicable, a DMF containing non-proprietary information about the device components and materials.
   • Regulatory History: Summary of regulatory approvals or clearances obtained in other countries, if any.

How to Prepare Application Files:

1. Gather and Organize Documents: Collect all required documents and organize them according to the NMPA's submission requirements. Ensure all documents are current, complete, and accurate.

2. Translation: Translate all documents into Chinese, as Chinese is the official language for submissions to the NMPA. Ensure translations are performed by qualified translators and are accurate.

3. Compile Technical Documentation: Prepare a comprehensive technical file that includes device specifications, manufacturing information, risk analysis, labeling, and instructions for use. Ensure all technical documents are consistent and aligned with regulatory requirements.

4. Clinical Data Compilation: Compile clinical evaluation reports and trial data, if applicable, to demonstrate device safety and efficacy. Ensure these documents are comprehensive and provide clear evidence supporting your device's performance.

5. Quality Management System: Include documentation demonstrating compliance with ISO 13485 or equivalent QMS standards. Ensure all QMS documents are up to date and reflect current practices.

6. Prepare Submission Package: Assemble all documents into a cohesive submission package. Include a cover letter summarizing the contents of the application and explaining how the device meets NMPA regulatory requirements.

7. Review and Finalize: Conduct a thorough review of the entire application package to ensure completeness and accuracy. Address any deficiencies or gaps identified during the review process.

8. Submit Application: Submit the application and all supporting documents through the NMPA's designated online portal or physically to the NMPA office, as per their specific submission instructions.

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