MEDTECH NEWS
China's NMPA Issues Regulatory Guidance on Reliability Evaluation for CT X-Ray Tube Assemblies
03 03 2026On February 28, 2026, China's NMPA Center for Medical Device Evaluation (CMDE) released Announcement No. 8, introducing new registration review guidance for the reliability evaluation of CT X-ray tube assemblies. The guidance establishes standardized requirements for manufacturers to define and validate a reliability index — covering service life, confidence levels, and scan capacity — through either verification or determination-based testing approaches, including both normal-condition and accelerated life testing. It also mandates Failure Mode, Effects, and Criticality Analysis (FMECA), performance testing across key parameters such as focal spot size, radiation dose, and image quality, and proper documentation in the registration dossier. Applicable to both standalone tube assembly registrations and those submitted as part of a complete CT system, this guidance signals China's continued drive to align its medical device regulatory standards with international benchmarks, and serves as essential reading for domestic and global manufacturers navigating NMPA market entry for CT-related products.