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China NMPA Newsletter – April 2024

2024-06-20

NMPA New Approvals in March 2024

In March 2024, NMPA approved 325 medical devices, including 29 Class III imported products, 30 Class II imported products, and 265 Class III domestic products.

Below is a list of approved Class III and Class II imported products in March 2024.

Medical Device/IVD Manufacturer Category
Hemodialysis Treatment Equipment Baxter Healthcare SA Class III
Princess VOLUME Lidocaine CROMA-PHARMA GmbH Class III
Introcan Safety 2 Closed IV Catheter B. Braun Melsungen AG Class III
Arthrex Fracture Plates and Screws Arthrex, Inc. Class III
Sonopet iQ Ultrasonic Aspirator System Stryker Instruments Class III
Diode laser system Lumenis Ltd. Class III
Sonopet iQ Ultrasonic Aspirator System Accessories Stryker Instruments Class III
Lumipulse® G PIVKA Ⅱ-N Fujirebio Inc. Class III
PreciControl EBV EBNA IgG Roche Diagnostics GmbH Class III
Ophthalmic Photocoagulator QUANTEL MEDICAL Class III
BOBBY Balloon Guide Catheter MicroVention, Inc. Class III
Dental Implant System HOOWON EDI CO.,LTD. Class III