The basic requirements for applying for NMPA certification of medical devices in China include:

1. Device Classification

• Determine the device's classification (Class I, II, or III) based on its risk level, as this influences the regulatory pathway.

2. Local Representation

• If the manufacturer is foreign, appoint a local agent or distributor familiar with Chinese regulations to facilitate the application process.

3. Quality Management System (QMS)

• Implement a QMS compliant with ISO 13485. This is crucial for demonstrating the device's quality and safety.

4. Technical Documentation

• Prepare a comprehensive technical file, including:
  • Device specifications and intended use
  • Manufacturing processes
  • Design and development documentation
  • Risk management files
  • Clinical evaluation data (if required)

5. Compliance with Standards

• Ensure compliance with Chinese national standards (GB standards) relevant to the device, as well as applicable international standards.

6. Clinical Data

• For Class II and III devices, provide clinical trial data to demonstrate safety and efficacy, conducted per Chinese regulations.

7. Labeling Requirements

• Ensure all labels and user instructions meet regulatory requirements, including language and content guidelines.

8. Application Submission

• Complete the NMPA application form and submit it along with all required documentation and fees.

9. Review Process

• Be prepared for a thorough review process by the NMPA, which may involve additional information requests.

10. Post-Market Obligations

• Establish procedures for post-market surveillance and reporting of adverse events to maintain compliance after approval.

Adhering to these requirements is crucial for a successful NMPA certification process.

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