For registering a Class II medical device with the NMPA (National Medical Products Administration) in China, follow these guidelines:

1. Pre-Registration Preparations

• Determine Classification: Confirm that your device is classified as Class II. This classification typically includes devices that pose a moderate risk and require more control than Class I.
• Identify Standards: Review relevant Chinese standards and regulations applicable to your device.

2. Prepare Required Documentation

• Application Form: Complete the NMPA application form.
• Company Information: Provide details about the manufacturer, including business license, manufacturing license, and quality management system (QMS) certification (ISO 13485 or equivalent).
• Device Information: Submit detailed information about the device, including:
  • Description and intended use.
  • Technical specifications and operating instructions.
  • Labeling and packaging.
• Clinical Data: Provide clinical evaluation reports or data demonstrating the safety and effectiveness of the device.
• Test Reports: Include reports from accredited laboratories showing compliance with Chinese standards (e.g., GB standards).

3. Submit the Application

• Online Submission: Register on the NMPA’s online platform (https://www.nmpa.gov.cn) and submit your application electronically.
• Physical Submission: Submit physical copies of the application and supporting documents to the NMPA office.

4. Technical Review

• Document Review: The NMPA will review the submitted documents for completeness and compliance with regulations.
• Technical Assessment: The NMPA may request additional technical information or clarification.

5. Testing and Inspection

• Testing: The device may need to undergo testing at a designated laboratory to ensure it meets Chinese standards.
• Inspection: The NMPA may conduct a factory inspection to verify the manufacturing processes and quality control.

6. Approval

• Registration Certificate: If the application is approved, the NMPA will issue a Registration Certificate.
• Post-Market Surveillance: Comply with post-market surveillance requirements, including reporting adverse events and maintaining records.

7. Renewal and Maintenance

• Renewal: Monitor the registration validity and renew it as required.
• Updates: Inform the NMPA of any changes to the device or manufacturing process.

Key Considerations:

• Local Representation: If you are a foreign manufacturer, you need a local representative in China to handle regulatory affairs.
• Language: Documentation should be translated into Chinese.

Make sure to stay updated with the latest NMPA regulations and guidelines as requirements may change.

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