MEDTECH NEWS
NMPA's Center for Medical Device Evaluation Releases Revised Guidelines for Endotracheal Tube Products (2026 Edition)
15 01 2026China's NMPA Center for Medical Device Evaluation has released revised registration guidelines for endotracheal tube products on January 9, 2026. The 2026 edition applies to Class II passive endotracheal tubes and establishes comprehensive requirements across regulatory documentation, technical specifications, non-clinical research, and labeling. Key provisions include mandatory risk management per GB/T 42062 standards, biocompatibility testing, sterilization validation with SAL of 1×10⁻⁶, and special labeling requirements for DEHP-containing PVC products. While endotracheal tubes remain exempt from clinical evaluation requirements, manufacturers must demonstrate product equivalence unless involving new materials or mechanisms.