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

1. Classification and Preliminary Assessment:

• Device Classification: Determine the correct classification of your device according to Chinese regulations. Class I devices are generally low-risk and non-invasive.

2. Preparation and Documentation:

• Technical Documentation: Prepare comprehensive technical documentation including device description, manufacturing process details, risk assessment, testing reports, instructions for use (IFU), and quality management system (QMS) documentation.

3. Local Agent Appointment:

• Appoint a Local Agent: If you are a foreign manufacturer, appoint a qualified local agent in China. The local agent represents you for regulatory affairs and communication with the NMPA.

4. Testing and Compliance:

• Conduct Testing: Ensure your device undergoes necessary testing to demonstrate compliance with Chinese standards and regulations. This may include biocompatibility, electrical safety, and performance testing.

5. Application Submission:

• Prepare Application: Compile and organize all required documentation according to NMPA requirements.
• Submission: Submit the application through the NMPA's electronic submission platform or through your local agent. Ensure all documents are accurately translated into Chinese.

6. Review and Evaluation:

• NMPA Review: The NMPA will review your application and technical documentation. This involves evaluating the safety, efficacy, and quality of your device based on submitted data and reports.
• Possible Requests: The NMPA may request additional information or clarification during the review process. Promptly provide any requested information to avoid delays.

7. Approval and Registration:

• Approval: Once the NMPA is satisfied with the documentation and compliance, they will issue a registration certificate for your Class I medical device.
• Registration: Upon receiving the registration certificate, your device is authorized for market entry and sale in China.

8. Post-Market Responsibilities:

• Post-Market Surveillance: Implement a post-market surveillance system to monitor device performance and safety. Report any adverse events or incidents to the NMPA as required.
• Compliance Updates: Stay informed about regulatory changes and updates. Maintain compliance with standards, labeling requirements, and periodic renewal of registration.

Key Considerations:

• Timeline: The overall timeline for Class I medical device registration can vary depending on the completeness of your application, NMPA workload, and regulatory updates.
• Local Representation: Working closely with your local agent is essential for navigating the regulatory process and ensuring compliance with Chinese regulations.
• Documentation Accuracy: Ensure all technical documentation is accurate, complete, and up-to-date to facilitate a smooth review process with the NMPA.

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