The process for Class II Medical Device NMPA registration in China involves several detailed steps to ensure compliance with regulatory requirements. Here is a comprehensive outline of the process and steps involved:

1. Determine Device Classification:

• Classification Confirmation: Verify that your medical device is classified as Class II according to China's regulatory classification rules. This determination affects the regulatory pathway and requirements.

2. Preparation of Technical Documentation:

• Compile Essential Documents: Gather comprehensive technical documentation, which typically includes:
  • Device description, specifications, and intended use
  • Design and manufacturing information
  • Risk analysis and assessment, including mitigation measures
  • Clinical evaluation data (if applicable)
  • Validated test reports demonstrating compliance with Chinese technical standards or equivalent international standards recognized by NMPA
  • Labeling and packaging information
  • Instructions for use
  • Quality management system documentation (e.g., ISO 13485 certification)

3. Appointment of Local Agent:

• Engage a Local Agent: As a foreign manufacturer, appoint a qualified local agent in China who will act as your official representative throughout the registration process. The local agent must have a registered office in China.

4. Conduct Testing and Obtain Certifications:

• Testing Requirements: Conduct necessary testing according to Chinese national standards or applicable international standards. Obtain test reports from accredited laboratories.
• Certifications: Ensure your device complies with relevant certifications, such as safety and performance certifications, required by Chinese regulations.

5. Application Submission:

• Online Submission: Submit your registration application through the China Medical Device Registration (CMDR) system, which is managed by NMPA.
• Documentation Submission: Upload all required documents and information accurately and completely. This includes technical files, test reports, quality management system documentation, and other relevant information.

6. Review and Evaluation:

• Regulatory Review: NMPA will review your application and technical documentation to assess compliance with regulatory requirements, including safety, efficacy, and quality management system.
• Feedback and Clarifications: Be prepared to respond to any queries or requests for additional information from NMPA during the review process.

7. Onsite Inspection (if applicable):

• Inspection Requirement: Depending on the risk classification and type of device, NMPA may conduct an onsite inspection of your manufacturing facilities or engage a third-party organization to verify compliance with Good Manufacturing Practice (GMP) standards.

8. Approval and Registration:

• Registration Certificate Issuance: If your application meets all requirements and passes the review process, NMPA will issue a registration certificate for your Class II medical device.
• Validity: The registration certificate is valid for a specified period, typically several years, after which renewal is required.

9. Post-Market Surveillance:

• Compliance Obligations: Comply with post-market surveillance requirements, including monitoring of adverse events, maintaining quality records, and reporting to NMPA as stipulated by regulations.

10. Renewal and Updates:

• Renewal Requirements: Renew your registration periodically as per NMPA regulations. Update your registration in case of significant changes to the device or manufacturing process.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn