Registering medical devices with the NMPA in China involves several key steps and requirements. Here are the detailed requirements for three common types of NMPA registrations:

1. Class I Medical Devices:

   • Documentation Required: Technical documentation demonstrating the safety and effectiveness of the device, including design drawings, specifications, and testing data.
   • Testing Requirements: For some Class I devices, testing may be required to demonstrate compliance with relevant Chinese standards.
   • Quality Management System: Implement a quality management system (QMS) compliant with Chinese regulations.
   • Application Process: Submit the application through the NMPA online portal or in person, including all required documentation.

2. Class II and Class III Medical Devices:

   • Documentation Required: Comprehensive technical documentation, clinical evaluation data (for Class III), and risk assessment reports.
   • Testing Requirements: Conduct testing according to Chinese standards or provide evidence of equivalent testing.
   • Quality Management System: Maintain a QMS certified to ISO 13485 or equivalent, with documentation demonstrating compliance.
   • Clinical Trials (for Class III): Provide clinical trial data conducted in China or data demonstrating clinical safety and performance.
   • Application Process: Submit a detailed application, including all technical documentation, clinical data (if applicable), and proof of quality management system certification.

3. Innovative Medical Devices (Priority Review):

   • Requirements: Devices deemed innovative may qualify for priority review.
   • Criteria: Innovation must demonstrate substantial clinical improvement or new technology that significantly advances medical treatment or diagnosis.
   • Fast Track Review: Expedited review process may apply, with reduced review times compared to standard applications.

4. Post-Market Surveillance:

   • Requirements: Implement a post-market surveillance plan to monitor device performance and adverse events.
   • Reporting: Report adverse events and product defects promptly to the NMPA as required by Chinese regulations.

These requirements may vary slightly depending on the specific classification and characteristics of the medical device. It's advisable to consult with a regulatory expert or local representative familiar with NMPA regulations to navigate the registration process effectively.

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