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2026 China NMPA Bluebook is here:
The new “Regulation for Medical Device Administration and Supervision”, Order 739 LDT was released on Mar 18, 2021. The effective date is June 1, 2021.
China NMPA moves fast to provide more details in support of the State Council “Regulation on the Supervision and Administration of Medical Devices”, to support
The NMPA published “Guidelines Revisions for 22 Class II Medical Devices” on March 17, 2021. Feedback needs to be submitted by April 17, 2021. It
NMPA issued 2020 Adverse Events Report on March 22, 2021, summarizing over 530,000 reports, 35.25% rise from the year before. “Medical device manufacturers should take
NMPA issued Notice regarding Medical Device Master Files Register on March 12, 2021. The draft was published in January 2019. Medical device master file in
New China NMPA Reform titled “Regulation on the Supervision and Administration of Medical Devices”, or Order 739, long-awaited overarching policy, is finally released. It was
Here’s the latest China regulatory and clinical affairs newsletter for medical device and IVDs pros in February 2021. These updates are presented by China Med
Here’s the latest China regulatory and clinical affairs newsletter for medical device and IVDs pros for January 2021. These updates are presented by China Med
An amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted by the China State Council on December 22, 2020. On
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
NMPA published “Clinical Evaluation Guideline on Medical Magnetic Resonance Imaging System with Same Variety” on February 1, 2021. The 16-page document provides manufacturers detailed pathway
NMPA issued the “2021 Medical Device Guidelines Revisions Plan” on February 9, 2021, in which 51 guidelines are affected. The revisions are aimed to facilitate