NMPA Website Announcement: On January 17, the National Medical Products Administration (NMPA) granted conditional emergency approval for the registration and market launch of an extracorporeal lung support device developed by Aerospace New Long March Medical Instrument (Beijing) Co., Ltd. This product is the second domestically produced ECMO device to be approved in China. During extracorporeal circulation, the device provides power and safety monitoring, and when used in conjunction with compatible single-use consumables, it achieves pulmonary function support. The product is suitable for adult patients suffering from acute respiratory failure whose conditions are difficult to control with other treatments and who face foreseeable risks of disease progression or death.
The product consists of a main unit, flow/bubble sensor, manual emergency drive device, manual emergency drive device bracket, pressure cable, oxygenator bracket, oxygen cylinder bracket, and a cart.
The marketing of this product will further enhance the supply capacity of ECMO products in China, meet urgent clinical needs, improve the treatment level for severe COVID-19 patients, and better achieve the goal of "protecting health and preventing severe cases" in COVID-19 prevention and control.
During the registration application process of this product, the National Medical Products Administration (NMPA) followed the principles of "unified command, early intervention, rapid efficiency, and scientific review" to establish an emergency review working group. This group assigned dedicated personnel, provided full-process guidance, issued technical review guidelines, enhanced guidance on product registration applications, and expedited the review and approval process.
The drug regulatory department will strengthen the post-marketing supervision of this product to protect the safety of patients using medical devices.