Preparing for NMPA (National Medical Products Administration) registration of medical devices in China involves gathering comprehensive documentation and ensuring compliance with regulatory requirements. Here’s a breakdown of the documents typically required and steps to prepare the application materials:

Required Documents for NMPA Registration:

1. Application Form: Complete and sign the application form provided by the NMPA.

2. Device Description and Specifications:

   • Detailed description of the medical device, including its intended use, indications, and technical specifications.

3. Design and Manufacturing Information:

   • Documentation outlining the device's design, manufacturing process, components, and materials used. Include details about sterilization methods if applicable.

4. Risk Assessment and Management:

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

5. Testing and Validation Reports:

   • Provide testing and validation data demonstrating the device's compliance with relevant standards and specifications. This may include:
     • Performance testing reports (e.g., electrical safety, mechanical testing).
     • Biocompatibility testing reports (to assess biological safety).
     • Stability testing data (if applicable, to demonstrate shelf-life and performance over time).

6. Clinical Evaluation Data (if applicable):

   • For higher-risk devices, clinical evaluation data may be required to demonstrate the device's safety and efficacy. Include clinical trial reports or literature-based evidence supporting the device's performance.

7. Labeling and Instructions for Use (IFU):

   • Provide labeling and IFU in Chinese. This includes packaging details, labeling content, and clear instructions for device assembly, use, maintenance, and disposal.

8. Quality Management System (QMS) Documentation:

   • Evidence of compliance with ISO 13485 or equivalent quality management standards. Include documents such as QMS manuals, procedures, and records demonstrating adherence to quality standards throughout the device lifecycle.

9. Declaration of Conformity:

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

Steps to Prepare Application Materials:

1. Review Regulatory Requirements:

   • Familiarize yourself with NMPA regulations and specific requirements for the classification of your medical device. Understand the documentation and testing standards applicable to your device.

2. Compile Technical Documentation:

   • Gather all required technical documentation, ensuring completeness and accuracy. This includes device specifications, design details, risk assessment reports, testing results, clinical data (if applicable), and QMS documentation.

3. Prepare Labeling and IFU:

   • Ensure that labeling and IFU are accurately translated into Chinese. Include all required information regarding device identification, usage instructions, warnings, and precautions.

4. Verify Compliance with Standards:

   • Conduct thorough checks to ensure that all documentation and testing results comply with relevant Chinese standards and regulations. Address any discrepancies or gaps identified during the review process.

5. Organize and Package Application Materials:

   • Organize all documents into a clear and structured format as per NMPA guidelines. Package the application materials securely and label them appropriately for submission.

6. Submit Application:

   • Submit the completed application materials through the NMPA's online registration platform or via your appointed local representative in China. Ensure that all forms are filled out accurately, and include payment of applicable fees.

7. Follow-Up and Respond to Requests:

   • Monitor the progress of your application. Be prepared to respond promptly to any requests for additional information or clarifications from the NMPA during the review process.

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