Applying for Class I medical device registration with China's National Medical Products Administration (NMPA) involves several steps, specific materials, and considerations to ensure compliance and successful registration. Here’s a detailed guide:

Process for Applying for Class I Medical Device Registration with China NMPA:

1. Classification Confirmation:

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

2. Appointment of Local Agent:

   • Foreign manufacturers must appoint a qualified local agent in China. The local agent will represent you for regulatory purposes and facilitate communications with the NMPA.

3. Prepare Technical Documentation:

   • Compile comprehensive technical documentation, including:
     • Device Description: Detailed description of the device, its intended use, and specifications.
     • Manufacturing Process: Information on how the device is manufactured, including materials used and processes involved.
     • Risk Assessment: Assessment of potential risks associated with the device and measures taken to mitigate these risks.
     • Testing Reports: 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 (QMS): 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. Compile Application Package:

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

6. Submit Application to NMPA:

   • Submit your application package electronically through the NMPA’s designated platform. Ensure all forms are completed accurately and all required documents are included.

7. Review and Approval:

   • 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.

Required Materials:

• Application Form: Provided by the NMPA, completed with accurate information.
• Technical Documentation: Detailed information about the device’s design, manufacturing, and testing.
• Quality Management System (QMS): Proof of compliance with ISO 13485 or equivalent standards.
• Clinical Data (if applicable): Only required if clinical evaluation is necessary for your device.
• Local Agent Appointment Letter: Confirmation of the appointment of a local agent in China.

Considerations:

• Regulatory Updates: Stay informed about changes in Chinese regulatory requirements and guidelines that may impact your device registration process.
• Language Requirements: Ensure that all documentation is translated into Chinese, as required by the NMPA.
• Timelines: The registration process timeline can vary based on the completeness of your application and the workload at the NMPA.
• Local Agent Support: A qualified local agent can provide valuable support in navigating the regulatory landscape, communicating effectively with the NMPA, and ensuring compliance throughout the registration process.

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