NMPA granted ten special statuses in August 2021, among them are seven innovation cardio devices: Boston Scientific Corporation: Vascular Plaque Atherectomy System TriReme Medical: Paclitaxel
NMPA issued the “Artificial Intelligence Medical Software Classification Guideline” on July 8, 2021, to direct manufacturers for the classification and the corresponding clinical data and
The NMPA granted four innovation review statuses on June 22, 2021, three innovation cardio devices which are cardiovascular-related and one for intraperitoneal surgery: Chengdu Sailanuo
On June 10, 2021, the NMPA issued the “Guideline of Shelf-life for Passive Implantable Medical Device”, directing type testing and regulatory submission for wide range