NMPA Medical Device New Approvals In April 2024


In April 2024, NMPA approved 292 medical devices, including 37 Class III imported products, 30 Class II imported products, and 224 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 April 2024.

Medical Device/IVDManufacturerCategory
Phoenix Atherectomy SystemVolcano AtheroMed Inc.Class III
CODMAN MICROSENSOR Kits and CereLink ICP Sensor KitsIntegra LifeSciences Production CorporationClass III
Factor VIII Test Kit (Coagulation Method)Roche Diagnostics GmbHClass III
Implantable Pulse GeneratorAbbott MedicalClass III
Vascular haemophilia factor test kit (immunoturbidimetric method)Roche Diagnostics GmbHClass III
U1trasound Bio MicroscopeArcScan, Inc.Class III
IntellaNav StablePoint Ablation CatheterBoston Scientific CorporationClass III
OPTIS Mobile Next Imaging SystemAbbott MedicalClass III
LASSOSTAR NAV Circular Mapping CatheterBiosense Webster, Inc.Class III
HeartLight EndoscopeCardioFocus, Inc.Class III
Stellaris Elite Vision Enhancement SystemsBausch & Lomb IncorporatedClass III
Disposable Thermal Biopsy ForcepsオリンパスメディカルシステムズClass III
Holmium Surgical LaserLumenis Ltd.Class III
RibFix Blu Thoracic Fixation SystemBiomet MicrofixationClass III
Sterile eye dropsEUSAN GmbHClass III
Lumipulse® G PIVKA II-N Calibrators setFujirebio Inc.Class III
ECCO2 Removal and Hemofiltration SystemMEDICA S.p.AClass III
da Vinci Xi Surgical SystemIntuitive Surgical, Inc.Class III
Brain Tissue Oxygen Partial Pressure and Temperature MonitorIntegra LifeSciences (Ireland) LtdClass III
HeartLight® Deflectable SheathCardioFocus, Inc.Class III
SimuForm Semi-Rigid Annuloplasty RingMedtronic, Inc.Class III
Clareon PanOptix Toric Trifocal Hydrophobic IOLAlcon Laboratories, IncorporatedClass III
In. Pact Admiral Paclitaxel-coated PTA Balloon CatheterMedtronic, Inc.Class III
TECNIS Synergy OptiBlue IOL with TECNIS Simplicity Delivery SystemJohnson & Johnson Surgical Vision,Inc.Class III
Constellation Probe KitAlcon Laboratories, Inc.Class III
Memo 4D Annuloplasty RingCorcym S.r.l.Class III
Core build-up compositeBisco, Inc.Class III
Medtronic Evolut PRO+ SystemMEDTRONIC INC.Class III
Dental Implant SystemInstitut Straumann AGClass III
GORE® TAG® Thoracic Branch EndoprosthesisW.L. Gore & Associates, Inc.Class III
Dental ImplantAlpha-Bio Tec Ltd.Class III
Universal Composite RestorativeDentsply DeTrey GmbHClass III
OPTIS Integrated Next Imaging SystemAbbott MedicalClass III
Medical Diagnostic X-ray SystemPhilips Medical Systems DMC GmbHClass III
ProGrip™ Laparoscopic Self-Fixating MeshSofradim ProductionClass III
Symplicity Spyral™ Multi-Electrode Renal Denervation CatheterMedtronic, Inc.Class III
Symplicity G3™ Renal Denervation RF GeneratorMedtronic, Inc.Class III
Treatment PackCarl Zeiss Meditec AGClass II
Kendall SCD 700 Sequential Compression SystemCovidien llcClass II
Disposable biopsy forcepsオリンパスメディカルシステムズClass II
ProTaper UltimateMaillefer Instruments Holding SàrlClass II
DAMON Q2 Drop-in HooksOrmco CorporationClass II
Pulmonary Function Testing SystemVyaire Medical GmbHClass II
Cyclosporine Reagent KitAbbott Ireland Diagnostics DivisionClass II
6C Plus Cell ControlBeckman Coulter, IncClass II
Iron3 (Iron3)Siemens Healthcare Diagnostics Inc.Class II
Programmers for Cardiac Implantable Devices and their external componentsBIOTRONIK SE & Co.KGClass II
X-Guide Planning SoftwareX-Nav Technologies,LLCClass II
Cochlear Wireless Programming Pod and Custom SoundCochlear LimitedClass II
Auto-InjectorPhillips-Medisize A/SClass II
Deep Brain Stimulator External Pulse GeneratorAbbott MedicalClass II
Merlin 2 Patient Care System ProgrammerSt. Jude Medical Cardiac Rhythm Management DivisionClass II
Dental Imaging SoftwareHDX WILL Corp.Class II
Lactate_3 (Lac_3)Siemens Healthcare Diagnostics Inc.Class II
Ophthalmic Surgical Instruments and AccessoriesMedOne Surgical, Inc.Class II
MaskResMed Pty LtdClass II
MaskResMed Pty LtdClass II
Single-use closure clips株式会社河野製作所Class II
ACUFEX Access Positioning KitSmith & Nephew Inc.Class II
Dissecting ToolsMedtronic Powered Surgical SolutionsClass II
ProTaper UltimateMaillefer Instruments Holding SàrlClass II
Biliary Dilation Catheterゼオンメディカル株式会社Class II
Dental drillsKJ MEDITECH CO., LTD.Class II
Flexor® Parallel™ Rapid Release™ Ureteral Access SheathCook IncorporatedClass II
NSE CalibratorsAbbott GmbHClass II
cobas GLU test stripsRoche Diagnostics GmbHClass II
AFIAS Cardiac TripleBoditech Med Inc.Class II
Sources: NMPA