China NMPA Newsletter – July 2024
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NMPA Medical Device New Approvals in June 2024
In June 2024, NMPA approved 134 medical devices, including 14 Class III imported products, 11 Class II imported products, and 109 Class III domestic products.
Below is a list of approved Class III and Class II imported products in June 2024.
| Medical Device/IVD | Manufacturer | Category |
| OptiCross 35 15 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | Class III |
| Cochlear Implant | MED-EL Elektromedizinische Geräte GmbH | Class III |
| Afterloader System | Varian Medical Systems, Inc. | Class III |
| SPECT/CT | GE Medical Systems Israel, Functional Imaging | Class III |
| HeartLight®X3 Catheter | CardioFocus, Inc. | Class III |
| ENT Treatment Guidance System | Medtronic Navigation, Inc. | Class III |
| Urgoclean Ag Pad | LABORATOIRES URGO | Class III |
| RAPID RHINO Epistaxis Device | ArthroCare Corporation | Class III |
| Arterial Catheter | Haolang Medical USA Corporation | Class III |
| FIBERGRAFT BG Putty Bone Graft Substitute | Prosidyan, Inc. | Class III |
| Sling for female urinary incontinence | Promedon S.A. | Class III |
| STANDARDTM Q HIV 1/2 Ab 3-Line Test | SD Biosensor, Inc. | Class III |
