Import approval for medical devices under NMPA (National Medical Products Administration) certification in China involves several regulatory requirements. These requirements ensure that all medical devices entering the Chinese market meet safety, efficacy, and quality standards. Here’s a comprehensive overview of the key regulatory requirements for obtaining import approval:

1. Classification of Medical Devices

• Determine Device Class: Medical devices in China are classified into three categories (Class I, II, and III) based on risk. The classification affects the regulatory pathway and approval requirements.
  • Class I: Low risk; subject to simplified registration and oversight.
  • Class II: Moderate risk; requires more stringent requirements and testing.
  • Class III: High risk; mandates extensive documentation, testing, and often clinical trials.

2. Local Agent Requirement

• Appointment of a Local Agent: Foreign manufacturers must appoint a local agent or representative in China who is responsible for the import approval process. This local agent acts as a liaison between the NMPA and the manufacturer.

3. Certificates and Documentation Required

• Business Licenses and Registration: The local agent must hold a valid business license and be registered to import medical devices.
• Product Technical Documentation: Comprehensive technical documentation must be submitted, including:
  • Product specifications
  • Manufacturing processes
  • Design control documents
  • Risk management reports
• Quality Management System Certification: Evidence of ISO 13485 or equivalent certification from a recognized authority should be provided.
• Clinical Evaluation Report: For Class II and III devices, a clinical evaluation report demonstrating safety and efficacy based on clinical data is required.
• Pre-market Testing Reports: Submit reports from recognized testing laboratories showing compliance with Chinese national standards (GB standards).
• Labeling and Instructions for Use: Labels must meet NMPA requirements, including being in Chinese and containing necessary instructions, warnings, and product information.

4. Product Registration Application Process

• Submission of Application: The local agent submits the product registration application along with all required documentation to the NMPA.
• Review Process: The NMPA reviews the submitted application and may request additional information or clarification.
• Technical Audit: Depending on the class of the device, a technical audit may be conducted, which could include an on-site inspection of the manufacturing facility.

5. Approval and Importation

• Issuance of Registration Certificate: If the application is approved, the NMPA issues a Registration Certificate, allowing for the importation and sale of the medical device in China.
• Customs Clearance: The registration certificate is required for customs clearance when importing the device into China. Ensure compliance with customs regulations.

6. Post-Market Surveillance and Reporting

• Implementation of Post-Market Surveillance: Manufacturers must establish a post-market surveillance (PMS) system to monitor the performance of the medical device once marketed.
• Reporting of Adverse Events: There are strict requirements for reporting any adverse events associated with the device to the NMPA.

7. Re-registration and Renewal

• Renewal Process: The registration for medical devices generally has a validity of 4 to 5 years, depending on the classification. Manufacturers need to apply for renewal before expiration, ensuring continuous compliance with regulations.

Conclusion

Navigating the regulatory framework for import approval of medical devices in China requires careful attention to detail and adherence to specified procedures. It’s essential for manufacturers to stay informed about current regulations and maintain communication with their local agent to facilitate the process effectively. If you have specific questions or need information about a particular device or certification, feel free to ask!

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