Index

February 19, 2021

One Hundred Innovative Medical Devices have been Approved by NMPA

By the end of 2020, 100 innovative medical devices have been approved by NMPA since the “Green Pathway” for innovative medical devices was created in 2014. This “Green Pathway” can […]
February 19, 2021

NMPA Released Five Guidelines in One Day

NMPA published five guidelines on January 19, 2021. The guidelines are put in place to guide manufacturers for local type testing, clinical trials, and regulatory approval. For IVD Products Technical […]
January 18, 2021

Another AI Software Approved by NMPA

NMPA granted Innovative Device Approval to the CT Imaging Assisted Pulmonary Nodule Detection Software produced by Hangzhou Deepwise on December 1, 2020. This is the second AI innovative product approved by […]
January 18, 2021

NMPA Released 12 Guidelines in One Day

The NMPA published twelve guidelines on December 9, 2020. Among all the guidelines, seven of them are for IVD products and five are for nomenclature. The guidelines were put in […]