For NMPA certification of medical devices in China, you need to comply with specific standards and certificate requirements:

1. Standards:

   • ISO 13485: This is a key standard for quality management systems for medical devices. Compliance is often required.
   • National Standards (GB): These are Chinese national standards that may apply to your device, such as GB 9706.1 for general safety requirements or GB 15810 for clinical thermometers.
   • IEC Standards: International Electrotechnical Commission (IEC) standards may also be relevant, especially for electrical safety and electromagnetic compatibility.

2. Certificate Requirements:

   • Device Classification: Medical devices are classified into three categories (Class I, II, III) based on risk. Class III devices require more extensive documentation and testing.
   • Technical Documentation: This includes device specifications, clinical trial data, and manufacturing processes.
   • Quality Management System Certificate: Evidence of compliance with ISO 13485 or equivalent.
   • Clinical Evaluation: For higher-risk devices, clinical data demonstrating safety and efficacy is required.
   • Safety and Performance Testing: Depending on the device, you may need to provide test reports for safety and performance.

Ensure all documents are prepared in accordance with NMPA guidelines and translated into Chinese if necessary.