The latest statistics from the National Medical Products Administration (NMPA) show that in the first half of this year, China approved 42 innovative medical devices for market launch, including several "world's first" products. These devices are meeting the clinical needs of Chinese patients while also offering Chinese solutions to the world.
Yuan Peng, Deputy Head of the Department of Medical Device Registration of the NMPA, said that from January to June this year, the NMPA approved a total of 1,595 Class III medical devices for market launch, including 42 innovative medical devices, with high-end innovative medical devices reaching the market at an accelerated pace.
According to the briefing, China's medical device registration system is divided mainly into Classes I, II, and III in ascending order of risk, with higher-risk devices subject to stricter regulatory requirements. Class III medical devices carry the highest risk level and are subject to product registration management in China, requiring special measures for strict control to ensure their safety and effectiveness. These include implantable devices, interventional devices, life-support equipment, and high-risk diagnostic and surgical equipment. Innovative medical devices are defined as devices that hold core invention patents, have working principles or mechanisms of action that are domestic firsts, feature internationally leading technology, and offer significant clinical application value.
It is understood that the 42 innovative medical devices approved this year include the world's first implantable brain-computer interface medical device and the world's first self-expanding, single-rivet, biodegradable atrial septal defect occluder, among others.
Yuan Peng noted that innovative medical devices such as donor perfusion systems, implantable wireless brain-computer interfaces, and ultra-high dose-rate electron beam radiotherapy systems have now been included in the "green channel" for the review and approval of "globally new" medical devices, putting China's R&D and innovation in high-end medical devices such as brain-computer interfaces on a track of rapid development.
(Excerpts)
Source: Xinwen Lianbo and CCTV News App
Yuan Peng, Deputy Head of the Department of Medical Device Registration of the NMPA, said that from January to June this year, the NMPA approved a total of 1,595 Class III medical devices for market launch, including 42 innovative medical devices, with high-end innovative medical devices reaching the market at an accelerated pace.
According to the briefing, China's medical device registration system is divided mainly into Classes I, II, and III in ascending order of risk, with higher-risk devices subject to stricter regulatory requirements. Class III medical devices carry the highest risk level and are subject to product registration management in China, requiring special measures for strict control to ensure their safety and effectiveness. These include implantable devices, interventional devices, life-support equipment, and high-risk diagnostic and surgical equipment. Innovative medical devices are defined as devices that hold core invention patents, have working principles or mechanisms of action that are domestic firsts, feature internationally leading technology, and offer significant clinical application value.
It is understood that the 42 innovative medical devices approved this year include the world's first implantable brain-computer interface medical device and the world's first self-expanding, single-rivet, biodegradable atrial septal defect occluder, among others.
Yuan Peng noted that innovative medical devices such as donor perfusion systems, implantable wireless brain-computer interfaces, and ultra-high dose-rate electron beam radiotherapy systems have now been included in the "green channel" for the review and approval of "globally new" medical devices, putting China's R&D and innovation in high-end medical devices such as brain-computer interfaces on a track of rapid development.
(Excerpts)
Source: Xinwen Lianbo and CCTV News App