NMPA Medical Device New Approvals In May 2024


In May 2024, NMPA approved 265 medical devices, including 40 Class III imported products, 27 Class II imported products, and 197 Class III domestic products.

China NMPA is constantly upgrading regulations and guidelines for medical device regulatory, clinical affairs and post market surveillance in latest years. BradyKnows elite team has extensive experiences to support the whole life cycle of medical device. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Below is a list of approved Class III and Class II imported products in May 2024.

Medical Device/IVDManufacturerCategory
Patient monitor日本光电工业株式会社Class III
Ethicon Megadyne Electrosurgical GeneratorMegadyne Medical Products Inc.Class III
Dry Eye Treatment InstrumentLumenis Ltd.Class III
bright CT (Oral and maxillofacial cone beam computed tomography equipment)(주)덴티움아이씨티사업부Class III
3D Printed Total Knee SystemSmith & Nephew, Inc.Class III
NobelProcera Abutment TitaniumNobel Biocare ABClass III
Self-etching/self-adhesive resin cementITENA CLINICALClass III
Avenir Complete Hip SystemZimmer Inc.Class III
Agent™ MONORAIL™ Paclitaxel-Coated PTCA Balloon CatheterHemoteq AGClass III
DIOnavi-P.MAXDIO CorporationClass III
iStent inject W Trabecular Micro-Bypass SystemGlaukos CorporationClass III
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc.Class III
PowerPICC Catheter with Sherlock 3CG Tip Positioning System (TPS) StyletBard Access Systems, Inc.Class III
Arthrex FiberTak Suture AnchorArthrex, Inc.Class III
Scepter Mini Occlusion Balloon CatheterMicroVention,Inc.Class III
PFM alloyPFM alloyThe Argen CorporationClass III
Zetuvit Plus/Zetuvit Plus Silicone/Zetuvit Plus Silicone BorderPaul Hartmann AGClass III
BIOLOX delta Universal Taper Ceramic HeadsHowmedica Osteonics Corp.Class III
Acetabular cup systemWaldemar Link GmbH & Co. KGClass III
Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for AstigmatismBausch & Lomb IncorporatedClass III
ST Internal Implant SystemMegaGen Implant Co.,Ltd.Class III
Diapact CRRT BloodlinesB.Braun Avitum AGClass III
Continuous Single Culture®-NX Complete (CSCM-NXC)FUJIFILM Irvine Scientific, Inc.Class III
Turnpike Gold CatheterVascular Solutions LLCClass III
Dental implant Abutment systemPointNix Co.,Ltd.Class III
Epic Plus Supra ValveAbbott MedicalClass III
Vitrectomy TipBausch&Lomb, IncorporatedClass III
SOFIA 88 CatheterMicroVention, Inc.Class III
UltrafilterGambro Dialysatoren GmbHClass III
Reso-PacHager & Werken GmbH & Co. KGClass III
Epic Plus ValveAbbott MedicalClass III
Biliary Stent SystemALLIUM Ltd.Class III
SDR Plus Bulk Fill FlowableDentsply CaulkClass III
TECNIS Eyhance IOL with TECNIS SimplicityTM Delivery SystemJohnson & Johnson Surgical Vision, Inc.Class III
Haemodialysis equipment東レ・メディカル株式会社Class III
Imaxeon Pty LtdImaxeon Pty LtdClass III
Implantable cardioverter defibrillatorAbbott MedicalClass III
Ultiri Measurement SystemAbbott MedicalClass III
Cardiac Resynchronization Therapy DefibrillatorAbbott MedicalClass III
Precision Treatment Planning SystemAccuray IncorporatedClass III
Body Composition AnalyzerBIOPARHOM SASClass II
Alinity i B·R·A·H·M·S PCT CalibratorsAbbott Ireland Diagnostics DivisionClass II
Automatic Blood and Body Fluid Analyserシスメックス株式会社Class II
XR-Series Automated Hematology AnalyzerSYSMEX CORPORATIONClass II
dental anesthesia systemDENTAL HI TECClass II
DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.Class II
Auto Ref-KeratometerPOTEC Co., LtdClass II
MassARRAY Dx SystemAgena Bioscience,Inc.Class II
Electrical Drill and Microdebrider HandpiecesMedtronic Xomed, Inc.Class II
S1820 Calibration Solution 1,S1830 Calibration Solution 2Radiometer Medical ApSClass II
EnSite™ X EP System Surface Electrode KitAbbott Medical Costa Rica Ltda.Class II
Lung function testingPulmOne Advanced Medical Devices,Ltd.Class II
Low Frequency Therapeutic Apparatus株式会社ホーマーイオン研究所Class II
Revised C-Reactive Protein Calibrator (RCRP CAL)Siemens Healthcare Diagnostics Inc.Class II
Wireless SpO2 SensorsMasimo CorporationClass II
Patient Interface DeviceLENSAR, IncClass II
FINESSE REFLEX DSP ForcepsAlcon Laboratories, Inc.Class II
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer SetCook IncorporatedClass II
Patient SafetyNetMasimo CorporationClass II
Regional Oximeter SensorMasimo CorporationClass II
Alinity i B∙R∙A∙H∙M∙S PCT ControlsAbbott Ireland Diagnostics DivisionClass II
Chattanooga Intelect F-SWSTORZ MEDICAL AGClass II
Revohem 0.025M Calcium Chloride SolutionSYSMEX CORPORATIONClass II
CT Medical Image Processing SoftwareGE MEDICAL SYSTEMS SCSClass II
CoaguChek INRangeRoche Diagnostics GmbHClass II
CoaguChek XS PT Test PSTRoche Diagnostics GmbHClass II
Sources: NMPA