The requirements for Class II Medical Device NMPA registration in China involve several key aspects that manufacturers and local agents must address to ensure compliance with Chinese regulatory standards. Here are the main requirements:

1. Technical Documentation:

• Device Description and Specifications: Detailed information about the device's intended use, design features, and specifications.
• Design and Manufacturing Information: Documentation outlining the device's design rationale, manufacturing process, and quality control measures.
• Risk Analysis and Assessment: Comprehensive risk analysis that identifies potential hazards associated with the device and includes risk mitigation strategies.
• Clinical Evaluation Data: Scientifically valid clinical data demonstrating the device's safety and efficacy, particularly for new technologies or where equivalence to existing devices cannot be established.
• Test Reports: Validated test reports demonstrating compliance with relevant Chinese national standards (GB standards) or equivalent international standards recognized by NMPA. This includes safety, performance, and biocompatibility testing.
• Labeling and Packaging Information: Clear labeling and packaging information in Chinese that complies with Chinese regulations, including essential information such as device name, specifications, manufacturer details, and usage instructions.
• Instructions for Use: Comprehensive instructions for use (IFU) that are clear and understandable for end-users, ensuring safe and effective device utilization.
• Quality Management System Documentation: Evidence of compliance with quality management system requirements, typically demonstrated through ISO 13485 certification or an equivalent quality system certification.

2. Clinical Evaluation:

• Clinical Data Requirements: Depending on the risk classification and nature of the device, clinical evaluation data may be required to demonstrate the device's safety and performance in clinical use.

3. Testing and Certifications:

• Testing Requirements: Conduct testing according to Chinese national standards (GB standards) or internationally recognized standards to demonstrate compliance with safety, performance, and other relevant requirements.
• Certifications: Obtain necessary certifications or test reports from accredited laboratories demonstrating compliance with applicable standards and regulations.

4. Regulatory Compliance:

• Compliance with Chinese Regulations: Ensure the device meets all applicable Chinese regulatory requirements, including safety, efficacy, quality, and labeling standards.
• GMP Compliance: For certain devices, demonstrate compliance with Good Manufacturing Practice (GMP) requirements through an onsite inspection or verification by a designated third party.

5. Appointment of Local Agent:

• Local Agent Requirements: 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 and be familiar with Chinese medical device regulations.

6. Application Submission and Review:

• Online Submission: Submit the registration application through the China Medical Device Registration (CMDR) system operated by NMPA.
• Review Process: NMPA will review the submitted documentation, including technical files, test reports, and quality management system documentation, to ensure compliance with regulatory requirements.

7. Post-Market Surveillance:

• Post-Market Obligations: After registration, comply with post-market surveillance requirements, including monitoring adverse events, maintaining quality records, and reporting to NMPA as required.

8. Renewal and Updates:

• Renewal Requirements: Periodically renew the registration certificate as per NMPA regulations. Update the registration in case of significant changes to the device or manufacturing process.

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