China NMPA has published a new arrangement for pre-registration technical consultation services for domestic class III medical device.
Please visit the link for the Chinese notification. 关于医疗器械受理前技术问题咨询工作安排调整的通告(2022年第37号) (cmde.org.cn)
Please visit the link for the Chinese notification. 关于医疗器械受理前技术问题咨询工作安排调整的通告(2022年第37号) (cmde.org.cn)
For the English translated ordinance, please refer to the attached pdf.
For details of the pilot run, please refer to the attached ppt.