China NMPA Newsletter – April 2024
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 |