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2024 China NMPA Bluebook is here:
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. For Priority Review, applicants for
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 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 System Suzhou Hongyuan: Chromosome Abnormality
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
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