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4 innovative products including implantable deep brain stimulation electrode lead kit approved for marketing
2024-05-28
Recently, the China NMPA approved the registration applications for 4 innovative products developed by Beijing PINS Medical Co., Ltd., including implantable deep brain stimulation electrode lead kit, dual channel rechargeable implantable deep brain stimulation pulse generator kit, dual channel implantable deep brain stimulation pulse generator kit and implantable deep brain stimulation extension lead kit.
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NMPA Announcement on Further Strengthening the Supervision and Administration of Entrusted Manufacturing by Registrants of Medical Devices (No.38, 2024)
2024-04-03
Pursuant to the implementation of the Regulations for the Supervision and Administration of Medical Devices, and with the objective of fully enforcing the primary responsibility for quality and safety on the part of the registrant of medical devices (hereinafter referred to as “Registrant”), this announcement aims to further strengthen the supervision and administration of entrusted manufacturing by registrants of medical devices, and enable effective prevention and control of quality and safety risks associated with medical devices.
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China Medical Device Standards Management Annual Report (2023)
2024-05-11
In 2023, China NMPA approved and issued 117 industry standard projects for medical devices, which were divided into formulation projects (57, 48.7%) and revision projects (60, 51.3%) according to the formulation and revision of standards.
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Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter and Symplicity G3™ Renal Denervation RF Generator Approved for Marketing
2024-04-30
Recently, the innovative products Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter and Symplicity G3™ Renal Denervation RF Generator of Medtronic, Inc. were approved by China NMPA.
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MoyoAssist® Extracorporeal Ventricular Assist Device and Extracorporeal Ventricular Assist Pump Head and Circuit Approved for Marketing
2024-04-28
Recently, the innovative products MoyoAssist® Extracorporeal Ventricular Assist Device and Extracorporeal Ventricular Assist Pump Head and Circuit of magAssist Inc. (Suzhou) were approved for marketing.
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Oligosaccharide Chain Detection Kit (Fluorophore-Assisted Carbohydrate Electrophoresis) Approved
2024-04-11
Recently, the innovative product Oligosaccharide Chain Detection Kit (Fluorophore-Assisted Carbohydrate Electrophoresis) of Jiangsu SysDiagno Biotech Co., Ltd. was approved by China NMPA.
