The NMPA (National Medical Products Administration) in China has established a comprehensive set of standards and regulations for the certification of medical devices. These standards ensure that devices are safe, effective, and of high quality before they are allowed on the market. Here’s an overview of the key standards and regulatory frameworks involved in the NMPA certification process:

### 1. **Classification Standards**

   - Medical devices in China are classified into three categories based on their risk levels:

     - **Class I**: Low-risk devices (e.g., bandages, non-invasive instruments).

     - **Class II**: Moderate-risk devices that require stricter controls (e.g., infusion pumps, diagnostic imaging).

     - **Class III**: High-risk devices (e.g., implantable devices, life-support equipment) that require extensive review and clinical data.

### 2. **Quality Management System Standards**

   - Manufacturers must comply with a quality management system (QMS) that aligns with **ISO 13485** standards. This includes:

     - Documentation of processes and procedures for design, manufacturing, and post-market activities.

     - Continuous improvement processes and internal audits.

### 3. **Safety and Performance Standards**

   - Devices must meet various safety and performance requirements. Key standards include:

     - **GB/T 14710**: General safety requirements for medical electrical equipment.

     - **GB 9706**: Specific standards for different categories of medical electrical devices.

     - **ISO 14971**: Risk management for medical devices, including risk analysis, evaluation, and control measures.

     - **IEC 60601**: Series of international standards for the basic safety and essential performance of medical electrical equipment.

### 4. **Labeling Standards**

   - Products must include appropriate labeling that complies with **GB 15979**, which outlines the requirements for product specifications, warnings, and instructions for use (IFU).

   - Labels must be in Chinese and must provide clear information on product use, contraindications, and safety precautions.

### 5. **Clinical Evaluation Standards**

   - Clinical data is often required to demonstrate the safety and effectiveness of Class II and Class III medical devices. Standards include:

     - **NMPA Guidelines for Clinical Evaluation of Medical Devices**: These guidelines outline requirements for conducting clinical trials and the type of data needed for registration.

     - **ISO 14155**: Clinical investigation of medical devices for human subjects—good clinical practice.

### 6. **Post-Market Surveillance Standards**

   - Manufacturers are required to set up and maintain a post-market surveillance system to monitor the performance of medical devices after they are marketed.

   - They must comply with regulations under **NMPA Order No. 739**, which provides details on post-market monitoring and reporting adverse events.

### 7. **Testing and Certification Standards**

   - Before submission, devices must undergo testing by a NMPA-recognized testing laboratory to ensure compliance with relevant safety and performance standards.

   - Manufacturers must submit test reports along with their application for NMPA certification.

### 8. **Regulatory Compliance Documents**

   - Manufacturers must provide necessary regulatory documentation, including:

     - Technical files

     - Product registration applications

     - Risk management reports

     - Evidence of compliance with applicable standards.

### Key Considerations

- **Updates and Revisions**: Standards and regulations can change, so it's crucial for manufacturers to stay updated with the latest NMPA requirements and relevant international standards.

- **Local Representation**: Foreign manufacturers need a local agent in China to facilitate communication with NMPA and assist in the certification process.

Overall, adhering to these standards is essential for obtaining NMPA certification and ensuring that medical devices are safe and effective for the Chinese market. If you need more detailed information about specific standards or regulations, let me know!

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