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Our monthly NMPA News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVD in China, for the month of June 2021. Policies Self-Test
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 Medical: Endovascular Aortic Stenosis System
The Guangdong government published the “Interim Provisions on the Administration of Imported Medicines and Medical Devices in Urgent Clinical Needs in the Guangdong-Hong Kong-Macao Greater Bay Area (draft)” on June
CMDE granted innovation and priority review status to four manufacturers in May, by which they can begin the fast-track application process. The complete list is as follows: Cardiovascular Medtronic: Leadless
The NMPA granted innovation and priority review status to eight manufacturers in April, by which they can begin the fast-track application process. The complete list is as follows: Cardiovascular Abbott:
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
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