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/IVD	Manufacturer	Category
Phoenix Atherectomy System	Volcano AtheroMed Inc.	Class III
CODMAN MICROSENSOR Kits and CereLink ICP Sensor Kits	Integra LifeSciences Production Corporation	Class III
Factor VIII Test Kit (Coagulation Method)	Roche Diagnostics GmbH	Class III
Implantable Pulse Generator	Abbott Medical	Class III
Vascular haemophilia factor test kit (immunoturbidimetric method)	Roche Diagnostics GmbH	Class III
U1trasound Bio Microscope	ArcScan, Inc.	Class III
IntellaNav StablePoint Ablation Catheter	Boston Scientific Corporation	Class III
OPTIS Mobile Next Imaging System	Abbott Medical	Class III
LASSOSTAR NAV Circular Mapping Catheter	Biosense Webster, Inc.	Class III
HeartLight Endoscope	CardioFocus, Inc.	Class III
Stellaris Elite Vision Enhancement Systems	Bausch & Lomb Incorporated	Class III
Disposable Thermal Biopsy Forceps	オリンパスメディカルシステムズ	Class III
Holmium Surgical Laser	Lumenis Ltd.	Class III
RibFix Blu Thoracic Fixation System	Biomet Microfixation	Class III
Sterile eye drops	EUSAN GmbH	Class III
Lumipulse® G PIVKA II-N Calibrators set	Fujirebio Inc.	Class III
ECCO2 Removal and Hemofiltration System	MEDICA S.p.A	Class III
da Vinci Xi Surgical System	Intuitive Surgical, Inc.	Class III
Brain Tissue Oxygen Partial Pressure and Temperature Monitor	Integra LifeSciences (Ireland) Ltd	Class III
HeartLight® Deflectable Sheath	CardioFocus, Inc.	Class III
SimuForm Semi-Rigid Annuloplasty Ring	Medtronic, Inc.	Class III
Clareon PanOptix Toric Trifocal Hydrophobic IOL	Alcon Laboratories, Incorporated	Class III
In. Pact Admiral Paclitaxel-coated PTA Balloon Catheter	Medtronic, Inc.	Class III
TECNIS Synergy OptiBlue IOL with TECNIS Simplicity Delivery System	Johnson & Johnson Surgical Vision,Inc.	Class III
Constellation Probe Kit	Alcon Laboratories, Inc.	Class III
Memo 4D Annuloplasty Ring	Corcym S.r.l.	Class III
Core build-up composite	Bisco, Inc.	Class III
Medtronic Evolut PRO+ System	MEDTRONIC INC.	Class III
Dental Implant System	Institut Straumann AG	Class III
GORE® TAG® Thoracic Branch Endoprosthesis	W.L. Gore & Associates, Inc.	Class III
Dental Implant	Alpha-Bio Tec Ltd.	Class III
Universal Composite Restorative	Dentsply DeTrey GmbH	Class III
OPTIS Integrated Next Imaging System	Abbott Medical	Class III
Medical Diagnostic X-ray System	Philips Medical Systems DMC GmbH	Class III
ProGrip™ Laparoscopic Self-Fixating Mesh	Sofradim Production	Class III
Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter	Medtronic, Inc.	Class III
Symplicity G3™ Renal Denervation RF Generator	Medtronic, Inc.	Class III
Treatment Pack	Carl Zeiss Meditec AG	Class II
Kendall SCD 700 Sequential Compression System	Covidien llc	Class II
Disposable biopsy forceps	オリンパスメディカルシステムズ	Class II
ProTaper Ultimate	Maillefer Instruments Holding Sàrl	Class II
DAMON Q2 Drop-in Hooks	Ormco Corporation	Class II
Pulmonary Function Testing System	Vyaire Medical GmbH	Class II
Cyclosporine Reagent Kit	Abbott Ireland Diagnostics Division	Class II
6C Plus Cell Control	Beckman Coulter, Inc	Class II
Iron3 (Iron3)	Siemens Healthcare Diagnostics Inc.	Class II
Programmers for Cardiac Implantable Devices and their external components	BIOTRONIK SE & Co.KG	Class II
X-Guide Planning Software	X-Nav Technologies，LLC	Class II
Cochlear Wireless Programming Pod and Custom Sound	Cochlear Limited	Class II
Auto-Injector	Phillips-Medisize A/S	Class II
Deep Brain Stimulator External Pulse Generator	Abbott Medical	Class II
Merlin 2 Patient Care System Programmer	St. Jude Medical Cardiac Rhythm Management Division	Class II
Dental Imaging Software	HDX WILL Corp.	Class II
Lactate_3 (Lac_3)	Siemens Healthcare Diagnostics Inc.	Class II
Ophthalmic Surgical Instruments and Accessories	MedOne Surgical, Inc.	Class II
Mask	ResMed Pty Ltd	Class II
Mask	ResMed Pty Ltd	Class II
Single-use closure clips	株式会社河野製作所	Class II
ACUFEX Access Positioning Kit	Smith & Nephew Inc.	Class II
Dissecting Tools	Medtronic Powered Surgical Solutions	Class II
ProTaper Ultimate	Maillefer Instruments Holding Sàrl	Class II
Biliary Dilation Catheter	ゼオンメディカル株式会社	Class II
Dental drills	KJ MEDITECH CO., LTD.	Class II
Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath	Cook Incorporated	Class II
NSE Calibrators	Abbott GmbH	Class II
cobas GLU test strips	Roche Diagnostics GmbH	Class II
AFIAS Cardiac Triple	Boditech Med Inc.	Class II

Sources: NMPA

NMPA Medical Device New Approvals In April 2024

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