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2026 China NMPA Bluebook is here:
The National Health Insurance Administration issued the “Reply to Recommendation No. 3298 of National People’s Congress” on March 4, in which the Administration agrees to
The following 32 innovative devices NMPA have been mentioned in 2022 Innovation Approval Notices published by the NMPA. China Med Device, LLC categorized them by
The NMPA granted innovation approvals to two radiology devices, used in combination for ultrasound imaging of intravascular lesions in coronary arteries. There have been 185
Proton Therapy Equipment, by APACTRON Particle Equipment Co., received the innovation approval on September 26, 2022. The NMPA released the review report for the proton
The NMPA granted Innovation Approvals to Medtronic and three others in May 2022: Medtronic: Transcatheter Implantable Leadless Pacing System Beijing Hengsheng: Disposable Intravascular Imaging Catheter
The NMPA granted innovative device status to seven devices, including two imported ones: Siemens Healthcare: X-ray Computed Tomography Equipment P+F Products + Features: Transcatheter Bicaval
The NMPA granted Innovation Approval to four neurological devices in January 2022: Beijing Pinchi: Dual-channel Implantable Deep Brain Stimulation System Beijing Pinchi: Implantable Spinal Cord
Three fast-track channels have been established by the NMPA to encourage innovation and deal with unmet medical needs: Innovation Approval, Priority Review, and Emergency Approval.
The NMPA released the “Communication Standards for Innovation Approval and Priority Review” on December 1, effective from the date of publication. The standards are to
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
The NMPA granted four fast-track statuses in July 2021, among them are two cardio devices: Innovation status Corindus: Coronary Artery Surgery Control System Shenyang Pengyue: Cardiac Cryoablation
The NMPA issued eleven Innovation Evaluation Reports for the 2nd Quarter of 2021, guiding overseas and domestic manufacturers on how to go through the fast-track