The quality standards for NMPA (National Medical Products Administration) certified medical devices in China are critical for ensuring the safety, efficacy, and quality of medical devices. These standards include a range of regulations, guidelines, and recognized international standards that manufacturers must adhere to throughout the lifecycle of their products. Here’s a detailed explanation of the main quality standards and key considerations:

### 1. **National Standards (GB Standards)**

   - **GB Standards**: In China, medical devices must comply with various **Guobiao (GB) Standards** set by the Standardization Administration of China. These encompass mandatory technical requirements, testing methods, and safety performance criteria specific to medical devices.

   - **Examples of GB Standards**: Some commonly referenced GB standards in the context of medical devices include:

     - **GB 9706.1**: General requirements for safety and essential performance of medical electrical equipment.

     - **GB 16142**: Requirements for the sterilizing agent used in sterilization of medical devices.

     - **GB/T 14710**: Testing methods for the safety of medical electrical equipment.

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