Applying for NMPA (National Medical Products Administration) certification for medical devices in China involves submitting a detailed application that includes a variety of specific information and documentation. Here’s a comprehensive breakdown of the required information:

1. General Information

• Applicant Information:
  • Name of the manufacturer.
  • Address and contact information.
  • Legal representative's name and contact details.
• Product Information:
  • Name and model of the medical device.
  • Intended use and indications for use.
  • Classification of the device (Class I, II, or III).
  • Specifications and technical parameters.

2. Technical Dossier

• Product Description:
  • Detailed description of the device, including design, materials, and intended function.
  • Diagrams, photos, and illustrations of the device and its components.
• Manufacturing Details:
  • Manufacturing processes and flowcharts.
  • Information about the manufacturing facility, including its location, layout, and equipment.
  • Quality control measures and specifications for production.

3. Quality Management System (QMS)

• ISO 13485 Certification:
  • Evidence of compliance with ISO 13485, including:
    • QMS manual.
    • Procedures for document control, design control, production control, and non-conformance management.
  • Internal audit reports and management review records.

4. Risk Management

• Risk Analysis:
  • A risk management report following ISO 14971 standards.
  • Identification of potential hazards, risk assessments, and risk control measures.

5. Clinical Evaluation Report (CER)

• Required for Class II and III devices:
  • Comprehensive evaluation of clinical data, including studies, literature, and any clinical trials conducted.
  • Justification of the device's clinical performance and safety.
  • Compliance with Chinese Good Clinical Practice (GCP) standards.

6. Testing Reports

• Pre-Clinical Testing:
  • Reports demonstrating compliance with applicable GB standards, including:
    • Biocompatibility testing reports (GB 15810).
    • Electrical safety and performance testing (GB 9706).
• Laboratory Certificates:
  • Certifications from NMPA-recognized testing laboratories.

7. Labeling and Instructions for Use (IFU)

• Labeling Requirements:
  • Proposed labels that comply with NMPA regulations, including:
    • Product name.
    • Manufacturer information.
    • Expiration date, if applicable.
    • Warnings and precautions.
• Instructions for Use:
  • Comprehensive user manual detailing:
    • Proper usage, indications, contraindications, and maintenance instructions.
    • Safety information and troubleshooting tips.
  • All documents should be translated into Mandarin Chinese.

8. Post-Market Surveillance Plan

• Outline the procedures for monitoring the device after market release, including:
  • Reporting adverse events and incidents.
  • Conducting periodic reviews and updates on device safety and effectiveness.

9. Legal Documents

• Business License:
  • A copy of the manufacturer's business license.
• Legal Representative Agreement:
  • Documentation confirming the appointment of a local legal representative in China.

10. Company Profile

• Overview of the Manufacturer:
  • Company history, experience in medical device manufacturing, and any relevant certifications.
• Organizational Structure:
  • An organizational chart showing key personnel and departments involved in the production and quality assurance of the device.

11. Financial Information

• Depending on the NMPA's requirements, you may need to provide financial information, such as the manufacturer’s ability to support post-market surveillance activities.

12. Other Supporting Documents

• Declaration of Conformity: A statement confirming that the device meets applicable regulations and standards.
• Previous NMPA Certifications: If applicable, include copies of previous certifications or registrations for similar products.

Conclusion

The application for NMPA certification requires meticulous preparation and attention to detail. Each section of the documentation must be thorough and comply with NMPA standards. Consulting with regulatory experts familiar with the NMPA process can significantly aid in ensuring that your application is complete and compliant, thereby reducing the likelihood of delays in the approval process.

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