The process for Class I medical device registration with China's National Medical Products Administration (NMPA) involves several key steps to ensure compliance and successful registration. Here’s a detailed overview of the process and steps:

Step-by-Step Process for Class I Medical Device Registration with China NMPA:

1. Confirm Device Classification:

   • Ensure that your device meets the criteria for Class I classification according to Chinese regulations. Class I devices are typically low-risk and non-invasive.

2. Appoint a Local Agent:

   • If you are a foreign manufacturer, appoint a qualified local agent in China who will act as your representative throughout the registration process and liaise with the NMPA on your behalf.

3. Prepare Technical Documentation:

   • Compile all necessary technical documentation required for registration. This may include:
     • Device description and specifications
     • Manufacturing process details
     • Risk assessment documentation
     • Testing reports (if applicable)
     • Instructions for use (IFU)
     • Quality management system documentation (e.g., 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. Compile Application Package:

   • Gather all required documents into a comprehensive application package. This typically includes:
     • Completed application form
     • Technical documentation as outlined above
     • Quality management system documentation
     • Proof of local agent appointment
     • Any additional regulatory declarations or certifications

6. Submit Application to NMPA:

   • Submit your application package to the NMPA electronically through their designated platform. Ensure that all documents are complete, accurate, and meet the regulatory requirements.

7. Review and Evaluation:

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

8. 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.

9. 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.

Important Considerations:

• Regulatory Updates: Stay informed about any changes or updates in Chinese regulatory requirements that may affect 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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