Class II Medical Device NMPA registration in China pertains to medical devices categorized as Class II according to China's regulatory system. These devices are considered moderate-risk and require regulatory approval from the National Medical Products Administration (NMPA) before they can be marketed and sold in China. Here’s how you can apply for Class II Medical Device NMPA registration:

Step-by-Step Guide to Apply for Class II Medical Device NMPA Registration:

1. Classification Determination:

   • Confirm that your device falls under Class II according to the Chinese classification rules. This determination is crucial as it dictates the regulatory pathway and requirements.

2. Compile Technical Documentation:

   • Prepare comprehensive technical documentation including:
     • Device description and specifications
     • Design and manufacturing information
     • Risk analysis and assessment
     • Clinical evaluation data (if required)
     • Labeling and packaging information
     • Instructions for use
     • Validated test reports (e.g., safety, performance testing)
     • Quality management system documentation

3. Local Agent Appointment:

   • As a foreign manufacturer, appoint a qualified local agent in China who will act as your official representative throughout the registration process.

4. Testing and Certification:

   • Conduct testing and obtain certifications from accredited laboratories. Ensure that your device complies with Chinese technical standards or equivalent international standards recognized by NMPA.

5. Application Submission:

   • Submit your registration application through the NMPA's online registration platform (the China Medical Device Registration (CMDR) system). Provide all required information and documentation accurately.

6. Review and Evaluation:

   • NMPA will review your application, technical documentation, and test reports. This process includes evaluating the device’s safety, efficacy, and quality management system.

7. Onsite Inspection (if required):

   • Depending on the risk classification and type of device, NMPA may require an onsite inspection of your manufacturing facilities. This inspection ensures compliance with Good Manufacturing Practice (GMP) standards.

8. Approval and Certification:

   • If your application meets all requirements and passes the evaluation, NMPA will issue a registration certificate for your Class II medical device. This certificate is necessary to legally market and distribute your device in China.

9. Post-Market Surveillance:

   • After registration, comply with post-market surveillance obligations, which include monitoring adverse events, maintaining quality records, and reporting to NMPA as required.

10. Renewal and Updates:

    • Renew your registration periodically as per NMPA requirements and update your registration in case of significant changes to the device or manufacturing process.

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