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.
China NMPA is constantly upgrading regulations and guidelines for medical device regulatory, clinical affairs and post market surveillance in latest years. BradyKnows elite team has extensive experiences to support the whole life cycle of medical device. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
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
Soft hydrophilic contact lenses
i-codi Co.,Ltd
Class III
TRANSPORT VENTILATOR
BIO-MED DEVICES, INC.
Class III
Anti-HBe2 Quality Control (aHBe2 QC)
Siemens Healthcare Diagnostics Inc.
Class III
High Frequency Surgical Unit
VIOL.Co.,Ltd.
Class III
LIAISON® Control HSV-1 IgG
DiaSorin Inc.
Class III
Sterile pen needles for single use
Novo Nordisk A/S
Class III
Aveir Catheter Product Family
Abbott Medical
Class III
AccuFill Bone Substitute Material
ETEX Corporation ETEX
Class III
Ion Endoluminal System
Intuitive Surgical, Inc.
Class III
Fully Articulating Catheter
Intuitive Surgical, Inc.
Class III
Calibra Veneer
Dentsply Caulk
Class III
Hydrus Microstent
Ivantis,Inc.
Class III
Abutment system
Cowellmedi Co., Ltd.
Class III
DEHT substitution line
B.Braun Avitum AG
Class III
TightRail Rotating Dilator Sheath
Philips Image Guided Therapy Corporation
Class III
Endo Clip™ III Auto Suture™ Clip Applier with Clip Logic™ Technology
Covidien llc
Class III
CAMLOG & CONELOG PROGRESSIVE-LINE Implants
ALTATEC GmbH
Class III
VITROS Immunodiagnostic Products TSH3 Calibrators
Ortho-Clinical Diagnostics
Class II
Automatic Phoropter
LUNEAU TECHNOLOGY OPERATIONS
Class II
Inactive Instruments and Accessories for Ion Endoluminal System
Intuitive Surgical, Inc.
Class II
Dornier Diode Laser Fibers
Dornier Medtech America,Inc.
Class II
Disposable Bipolar Radiofrequency Surgical Electrode Set
