Preparing the necessary documentation for NMPA certification of medical devices in China is a critical step in the registration process. The documentation needs to be comprehensive, accurate, and compliant with NMPA regulations. Here’s a detailed guide on the essential documents and how to prepare them:

1. Application Form

• NMPA Registration Application Form: Complete the official application form provided by the NMPA, ensuring all sections are accurately filled out, including product details, manufacturer information, and legal representative details.
• Signatures: Ensure the application form is signed by authorized personnel from the manufacturer.

2. Product Technical File

The technical file serves as the cornerstone of the application and should include the following:

• Product Description:

  • Detailed description of the medical device, including its intended use, specifications, and components.
  • Diagrams and photos of the device, including packaging.

• Manufacturing Information:

  • Information on the manufacturing process, including flowcharts, critical manufacturing steps, and control measures.
  • Details about the production facility, including layout, equipment, and operational procedures.

• Quality Management System (QMS):

  • Evidence of compliance with ISO 13485. Include your QMS documentation, procedures, and relevant policies.
  • Copies of internal audit reports and management reviews.

• Risk Management:

  • Risk analysis report following ISO 14971, detailing identified risks, their assessments, and risk control measures implemented.

3. Clinical Evaluation Report (CER)

• Clinical Data: For Class II and III devices, prepare a CER that includes:

  • Clinical data collected from studies, literature, or previously published works.
  • Evaluation of the clinical performance and safety of the device.
  • Justification for any reliance on international data.

• Compliance with GCP: Ensure the clinical evaluations comply with Chinese Good Clinical Practice (GCP) standards.

4. Testing Reports

• Pre-Clinical Testing: Include reports demonstrating compliance with Chinese GB standards:
  • Performance testing reports.
  • Safety testing reports for biocompatibility, electrical safety, and EMC (if applicable).
• Laboratory Certificates: Provide certifications from NMPA-recognized testing labs, confirming that tests were conducted according to relevant standards.

5. Labeling and Instructions for Use

• Labels: Include proposed labeling that complies with NMPA regulations, including:
  • Product name.
  • Manufacturer's name and address.
  • Manufacturing date and batch number.
  • Expiration date (if applicable).
• Instructions for Use (IFU): Provide detailed user instructions, including indications, contraindications, warnings, and proper usage instructions. Ensure translations are accurate and comply with NMPA guidelines.

6. Post-Market Surveillance Plan

• Outline your post-market surveillance strategy, including:
  • Monitoring mechanisms for adverse events.
  • Procedures for reporting incidents to NMPA.
  • Plans for periodic safety updates.

7. Legal Documents

• Business License: Include a copy of the manufacturer’s business license and any relevant import/export permits.
• Legal Representation Agreement: If applicable, provide documentation confirming the appointment of a local legal representative in China.

8. Company Profile and History

• Overview: Include an overview of the company, its history, and experience in manufacturing medical devices.
• Organizational Structure: Provide a chart outlining the organizational structure, especially relevant departments involved in the device’s production and quality assurance.

9. Additional Supporting Documents

• Declaration of Conformity: A document stating that the product complies with applicable regulations and standards.
• Previous NMPA Certifications (if any): If the company has prior NMPA registrations, include copies of these certificates as evidence of regulatory compliance.

10. Translation Requirements

• Ensure all documents are translated into Mandarin Chinese by a certified translator. This includes technical files, labels, user manuals, and any other supporting documentation.

Conclusion

Each document should be meticulously prepared, clearly organized, and consistent throughout. Ensure that all documents are checked for completeness and compliance before submission to avoid delays in the certification process. Engaging with regulatory experts or consultants familiar with NMPA requirements can further enhance the likelihood of a successful application.

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