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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 |
|
China NMPA Implements Revised Classification Catalog for In Vitro Diagnostic
Reagents
On May 21 2024, the China NMPA has announced the implementation of the revised
Classification Catalog for In Vitro Diagnostic Reagents (the Catalog) in
accordance with the Regulations for the Supervision and Administration of
Medical Devices (State Council Order No. 739). This revision, aimed at enhancing
the regulatory framework for in vitro diagnostic (IVD) reagents, is set to take
effect on January 1, 2025.
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