To apply for Class I medical device registration with China's National Medical Products Administration (NMPA), you'll need to meet several key requirements. Here’s a detailed breakdown of the requirements:

Requirements for Class I Medical Device Registration with China NMPA:

1. Device Classification Confirmation:

   • Confirm that your medical device meets the classification criteria for Class I as per Chinese regulations. Class I devices are typically low-risk and non-invasive.

2. Appoint a Local Agent:

   • Foreign manufacturers must appoint a qualified local agent in China. The local agent acts as the representative for regulatory affairs and communications with the NMPA.

3. Technical Documentation:

   • Prepare comprehensive technical documentation, which typically includes:
     • Device Description and Specifications: Detailed description of the device, its intended use, and specifications.
     • Manufacturing Process Details: Information on how the device is manufactured, including materials used and processes involved.
     • Risk Assessment Documentation: Assessment of potential risks associated with the device and measures taken to mitigate these risks.
     • Testing Reports: Any relevant testing reports demonstrating the device’s safety and performance.
     • Instructions for Use (IFU): Clear and comprehensive instructions for users on how to correctly use the device.
     • Quality Management System Documentation: Evidence of compliance with quality management system standards, such as ISO 13485 certification.

4. Clinical Evaluation (if required):

   • Determine if a clinical evaluation is necessary for your device. Class I devices generally do not require clinical trials unless specific circumstances warrant it.

5. Application Form:

   • Complete the official application form provided by the NMPA. This form captures essential details about your device and its intended use.

6. Quality Management System (QMS):

   • Ensure that your manufacturing facility and processes comply with relevant quality management system standards. Certification to ISO 13485 is typically required or beneficial.

7. Regulatory Declarations and Certificates:

   • Provide any additional regulatory declarations or certificates required by the NMPA, which may include compliance with specific Chinese standards or directives.

8. Submission and Payment:

   • Submit your application package electronically through the NMPA’s designated platform. Ensure all required documents are included and the application fee is paid, if applicable.

9. Review and Approval:

   • The NMPA will review your application and documentation. They may request additional information or clarifications during the review process.

10. Issuance of Registration Certificate:

    • Upon successful review and approval, the NMPA will issue a registration certificate for your Class I medical device. This certificate allows you to legally market and distribute your device in China.

11. Post-Market Surveillance:

    • After obtaining registration, comply with post-market surveillance requirements. This includes monitoring and reporting adverse events, maintaining updated technical documentation, and ensuring ongoing compliance with Chinese regulations.

Key Considerations:

• Regulatory Updates: Stay informed about any changes or updates in Chinese regulatory requirements that may impact your device registration process.
• Timelines: The registration process timeline can vary based on the completeness of your application and the workload at the NMPA.
• Local Representation: Having a local agent is crucial for effective communication with the NMPA and navigating regulatory processes in China.

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