China NMPA Newsletter – May 2024


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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.