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The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen,
The NMPA granted Innovation Approvals to the following devices in July 2022: Cardiovascular Transcatheter prosthetic pulmonary valve system Implantable left ventricular assist system Radiology Gamma beam stereotactic radiation therapy system
The NMPA published “Implementation Plan for Supporting Hong Kong and Macao Drug Market Authorization Holders to Produce Drugs and Medical Devices in 9 Mainland Cities in the Greater Bay Area
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 direct manufacturers on what to
The NMPA granted innovation approval to Suzhou LinaTech for the electron linear accelerator, and CMDE (Center for Medical Device Evaluaiton) issued the Review Report for the equipment. Indication and composition
The NMPA granted Innovation Approval to four medical devices in the first week of November 2021: Zhongyi Kangwei: Preimplantation Chromosome Aneuploidy Detection Kit Zhuo Ruan Medtech: Biological Hernia Repair Patch
The NMPA granted Innovation Approval to three medical devices in September 2021: Dental implant surgery navigation and positioning equipment Ultrasonic diagnostic equipment for endoscope Transcatheter aortic valve and retrievable delivery
Guangdong government published three documents on July 19, 2021 for feedback: Key Points for Application Materials for Import and Use of Hong Kong and Macau Medical Devices by Designated Institutions
NMPA granted nine manufacturers innovation approval and priority review status, including four overseas ones. The List Oncology Mevion Medical Systems: Proton Therapy System Biosense Webster (Israel): Magnetic Positioning Multi-channel Pulsed
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
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