China NMPA Newsletter – May 2024
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.
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 |
