The application process for NMPA (National Medical Products Administration) Class II registration of medical devices in China is structured and involves several detailed steps:

1. Classification Determination

First, classify your medical device according to NMPA guidelines. Class II devices generally pose moderate risk to users and may include devices like infusion pumps, ultrasound equipment, and certain diagnostic devices.

2. Technical Documentation Preparation

Prepare comprehensive technical documentation. This typically includes:

• Device Description: Detailed specifications, intended use, and components.
• Design and Manufacturing Information: Detailed drawings, manufacturing processes, and materials used.
• Risk Assessment: Identify potential risks associated with the device and describe mitigation measures.
• Testing Data: Performance testing (e.g., mechanical, electrical), biocompatibility testing, sterilization validation, and any other applicable tests.
• Clinical Evaluation: Clinical data supporting safety and performance claims, if required.
• Labeling and Instructions for Use: Labeling content in Chinese, including indications for use, warnings, and precautions.

3. Quality Management System (QMS) Compliance

Ensure your manufacturing facility complies with relevant QMS standards, typically ISO 13485. Obtain QMS certification and provide evidence of compliance.

4. Clinical Evaluation

If required, conduct clinical evaluations according to NMPA requirements. This involves reviewing existing clinical data or conducting new studies to demonstrate device safety and effectiveness.

5. Testing

Perform testing according to Chinese standards and regulations. This includes tests to verify device performance, safety, and compliance with specific technical standards applicable to your device category.

6. Technical Review and Application Submission

Compile all documentation and submit your application to NMPA through the China Medical Device Registration (CMDR) system. The application should include:

• Completed application form.
• Comprehensive technical dossier.
• Testing reports and data.
• Clinical evaluation report (if applicable).
• QMS certification and manufacturing facility information.
• Any other required documentation specified by NMPA.

7. Technical Review Process

NMPA will conduct a thorough review of your application, technical documentation, and test reports. This review evaluates whether your device meets Chinese regulatory requirements for safety, efficacy, and quality.

8. On-Site Inspection (if applicable)

Depending on the risk classification and other factors, NMPA may conduct on-site inspections of your manufacturing facilities to verify compliance with QMS and regulatory requirements.

9. Approval and Registration

Upon successful completion of the technical review and any necessary inspections, NMPA will issue an approval and registration certificate. This certificate allows your device to be legally marketed and sold in China.

10. Post-Market Surveillance

Implement post-market surveillance activities as required by NMPA. This involves monitoring the performance and safety of your device in the market and reporting any adverse events or product issues to NMPA.

Navigating the application process for NMPA Class II registration requires careful attention to detail, compliance with Chinese regulations, and potentially the expertise of a local regulatory consultant familiar with NMPA requirements. This consultant can help ensure your application is complete, accurate, and meets all necessary criteria for approval.

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