NMPA certification in China follows several key standards:

1. GB Standards: National standards for medical devices, which include safety, performance, and quality requirements. Devices must meet these specific standards to ensure compliance.

2. ISO 13485: A quality management system standard that must be adhered to for manufacturing medical devices, ensuring consistent quality and regulatory compliance.

3. Clinical Trial Guidelines: If applicable, devices must meet guidelines for clinical trials as outlined by the NMPA, including protocols for conducting and reporting trials in China.

4. Good Manufacturing Practice (GMP): Compliance with GMP requirements specific to medical devices, which include proper manufacturing processes and quality control measures.

5. NMPA Technical Guidelines: Specific guidelines provided by the NMPA for different types of medical devices, detailing additional requirements and procedures.

Meeting these standards is essential for obtaining and maintaining NMPA certification and ensuring that medical devices are safe and effective for the Chinese market.