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2025 China NMPA Bluebook is here:
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
The NMPA granted innovative device status to 27 medical devices from July to September 2023: Cardiovascular Chemistry Dermatology Gastroenterology/Urology General hospital Neurology Oncology Ophthalmic Radiology Key Takeaways for Overseas Manufacturers
NMPA issued the notice “Soliciting Feedback of Guideline on Medical Device Human Factors Design for the Second Time” on October 11, 2023, after the first round released in May 2020.
Hainan government issued the “Administrative Measures of Clinically Urgent Imported Drugs and Medical Devices Taken Out of the Hospital in Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in September 2023. These updates are presented by China Med Device, LLC, your partner
Picture: Grace Palma, CEO of China Med Device, LLC in RWD workshop in Hainan The NMPA published the “Guideline on Medical Device Real World Study Design Statistical Analysis (Draft)” today,
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