The nanosecond pulsed electric field cardiac ablation (nsPFA) system is the world's first revolutionary cardiac electrophysiology therapy product based on high repetition rate high voltage nanosecond pulses. It utilizes the irreversible electroporation effect of high voltage nanosecond pulses on cells to achieve selective ablation of myocardial tissue for the treatment of arrhythmia diseases. The research and development of this product has been supported by the Ministry of Science and Technology "Key Special Project for Major Scientific Instrument and Equipment Development". At present, more than 160 cases of clinical application have been completed, with significant curative effect and great social and economic benefits. On August 23,2023, in accordance with the requirements of Special Review Procedures for Innovative Medical Devices issued by National Medical Products Administration (Announcement No.83 [2018] of NMPA), the Office of Innovative Medical Device Review organized relevant experts to review the application for special review of innovative medical devices, and the project entered the special review procedure (No.6 [2023])