In March, 2020, NMPA has approved a total of 172 medical devices. 131 of them are domestic Class III medical devices, 18 of them are imported Class III medical devices, 22 of them are imported Class II medical devices and 1 of them is from the Taiwan medical device.

On March 25, 2020, CMDE released an announcement of review results on green pathway for two innovative medical devices, i.e., “Multi-branch Artificial Vascular Endurant Stent Graft System” and “Metal 3D Printed Sacrum Fusion” from Percutek Therapeutics and AK Medical respectively.

On April 9, 2020, NMPA announced that 12 medical device industry standards and an amendment have been approved. Details about the standards and amendment is listed in the table below for your reference. Bradynuoen can help manufacturers to evaluate the gap between your products and new guidelines.

China released the results of urgent approved clinical trials of medical devices against COVID-19.

On March 26, 2020, NMPA approved Allergan, Inc.’s registration of glaucoma implant, which is the first manufacturer to gain the approval with real world data in China. In June 2019, NMPA and Hainan Provincial Government jointly ran Hainan’s clinical real-world data pilot application. The real world data are used to justify the ethnic differences between China population and overseas population. The principle of real world data is focused on patient follow up data and the sample size is very small based on overseas clinical data. Bradynuoen is helping another client following Hainan pathway to get approval. Please do not hesitate to contact us if you need any help.

In February, 2020, NMPA has approved a total of 170 medical devices. 118 of them are domestic Class III medical devices, 16 of them are imported Class III medical devices, 32 of them are imported Class II medical devices and 4 of them are Hongkong, Macao or Taiwan medical device.