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2026 China NMPA Bluebook is here:
NMPA issued the “Key Points and Principles for Medical Device Clinical Trial Inspections (Draft) on November 28, 2023. Feedback needs to be submitted by December
The NMPA granted Innovation Approval to five medical devices in November 2023, including two additive manufactured devices: For an English copy of the “Tech Guide
Eighteen newly-established or revised industry standards were released by NMPA on November 24, 2023, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory
The NMPA granted innovation approvals to Zap Surgical’s head and neck X-ray stereotactic radiosurgery system and issued a review report. It is the seventh imported
NMPA conducted quality inspection on eleven types of medical devices and released the result on November 14, 2023. Twenty manufacturers are found incompliance, including three
The NMPA issued the innovation approval review report for Varian’s Proton Therapy System. It is the seven imported innovative device approved by the NMPA so
NMPA granted innovation approval to Varian’s Proton Therapy System on November 1, 2023. What’s the Device This product consists of an accelerator subsystem and a
NMPA released the “Clinical Evaluation Guideline on Artificial Intelligence-assisted Detection Medical Devices (Software)” on November 7, 2023. The guideline refers to FDA guidance of “Computer-Assisted
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in October 2023. These updates are presented by China
The NMPA issued an inspection result on October 25, 2023, for the inconsistence of manufacturing addresses. NMPA organized a remote inspection of XVIVO Perfusion AB,
NMPA published 54 draft guidelines on October 25, 2023, for feedback. Feedback needs to be submitted by November 23, 2023. Significance of Device Guidelines The
NMPA granted innovation approval to Siemens’s X-ray computed tomography equipment on October 17, 2023. What’s the Device In the approval notice, NMPA says that “the