Process for Class II Medical Device NMPA Registration in China:

1. Determine Device Classification:

• Confirm that your medical device falls under Class II according to Chinese regulatory classification rules.

2. Compile Technical Documentation:

• Device Description and Specifications: Detailed description of the device, its intended use, and technical specifications.
• Design and Manufacturing Information: Documentation on the device's design rationale, manufacturing process, and quality control measures.
• Risk Analysis and Assessment: Comprehensive analysis of potential risks associated with the device and risk mitigation strategies.
• Clinical Evaluation Data: Scientific data demonstrating the device's safety and efficacy, especially if new technologies are involved or equivalence to existing devices cannot be established.
• Test Reports: Validated reports from accredited laboratories demonstrating compliance with relevant Chinese national standards (GB standards) or recognized international standards.
• Labeling and Packaging Information: Clear labeling and packaging details in Chinese, meeting Chinese regulatory requirements.
• Instructions for Use: Comprehensive and clear instructions for use (IFU) in Chinese.
• Quality Management System Documentation: Evidence of compliance with quality management system requirements, often evidenced by ISO 13485 certification or equivalent.

3. Appointment of Local Agent:

• Engage 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. Testing and Certifications:

• Conduct necessary testing according to Chinese standards or equivalent international standards recognized by NMPA. Obtain certificates or test reports from accredited laboratories.

5. Application Submission:

• Submit the registration application through the China Medical Device Registration (CMDR) system online, managed by NMPA. Ensure all required documents are accurately uploaded.

6. Review and Evaluation:

• NMPA reviews the application, technical documentation, and test reports to assess compliance with regulatory requirements. This process may involve feedback and clarification requests.

7. Onsite Inspection (if required):

• Depending on the device classification and risk assessment, 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:

• Upon successful review and inspection (if applicable), NMPA issues a registration certificate for the Class II medical device, allowing it to be legally marketed and distributed in China.

9. Post-Market Surveillance:

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

10. Renewal and Updates:

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

Considerations:

• Regulatory Expertise: Engage with regulatory consultants or legal experts with knowledge of Chinese medical device regulations to ensure compliance and streamline the registration process.
• Translation Requirements: Ensure all documents are translated into Chinese where necessary, as Chinese is the official language for regulatory submissions in China.
• Timelines: The registration process can be lengthy, typically taking from 12 to 18 months or more, depending on the complexity of the device and regulatory updates.
• Costs: Budget for expenses related to consultancy fees, testing and certification costs, local agent fees, and potential onsite inspection expenses.

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