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2023 China NMPA Bluebook is here:
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 on Customized Additive Manufactured (3D
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 submissions. Mandatory Standards Recommended Standards
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 innovative device approved by the
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 overseas companies making soft contact
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 far in 2023, after Medtronic,
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 treatment subsystem. The accelerator subsystem
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 Detection Devices Applied to Radiology
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 Med Device, LLC, your partner
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, a Swedish medical technology company.
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 guidelines are prepared by NMPA
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 product consists of a scanning
A total of 23 imported devices issued voluntary recall notices from July to September 2023. Affected manufacturers include Medtronic, Siemens, Abbott, Covidien, Johnson & Johnson, etc. Many of these devices
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