NMPA New Approvals In February 2024


In February 2024, NMPA approved 193 medical devices, including 21 Class III imported products, 22 Class II imported products, and 148 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 February 2024.

Medical Device/IVDManufacturerCategory
GentleMax Pro PlusCandela CorporationClass III
Composite QC level 2東ソー株式会社Class III
X-ray computed tomography equipmentGEヘルスケア・ジャパン株式会社Class III
External Ventricular DrainageEconomicHP BIOPROTESES LTDAClass III
ACUVUE OASYS MAX 1-DAY Contact LensesJohnson & Johnson Vision Care, Inc.Class III
PTCA guidewire朝日インテック株式会社Class III
Preloaded Intraocular LensHOYA Medical Singapore Pte. Ltd.Class III
Target Detachable CoilsStryker NeurovascularClass III
Orsiro Mission Sirolimus Eluting Coronary Stent SystemBIOTRONIK AGClass III
Trabecular Metal Reverse Plus Shoulder SystemZimmer Inc.Class III
MicroCatheter株式会社カネカClass III
Double WireTM and Single Wire Sternum SutureA&E Medical CorporationClass III
Xpede Bone CementMedtronic Sofamor Danek USA, Inc.Class III
Pace/Sense LeadBoston Scientific CorporationClass III
Implantable Deep Brain Neurostimulation Extension LeadsMedtronic Inc.Class III
CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences (Ireland)LtdClass III
Composite QC level 3東ソー株式会社Class III
Maxium Smart CGebrüder Martin GmbH & Co. KGClass III
Aveir Leadless Pacemaker VRAbbott MedicalClass III
Burr Hole DeviceMedtronic Inc.Class III
HemosIL D-Dimer ControlsInstrumentation Laboratory CompanyClass II
Elecsys Vitamin D total IIIRoche Diagnostics GmbHClass II
PlasmaBlade Electrosurgical DeviceMedtronic Navigation, Inc.Class II
Disposable sterile surgical suitJiangxi 3L Medical Products Group (Cambodia) Co., Ltd.Class II
Disposable anesthetic gas absorberLABORATOIRES FANNAMEXClass II
Single-use endoscopic specimen retrieval bag(주)세종메디칼Class II
Rigid Hysteroscopy instrumentsDELMONT IMAGINGClass II
Navigated Pak NeedleBoston-Endo Surgical Technologies, Division of Lacey Manufacturing Company, LLCClass II
Acuity Universal CutterBoston Scientific CorporationClass II
Orthodontic Single Patient KitOrmco CorporationClass II
LED Curing Light3M Deutschland GmbHClass II
Acid Oxidation Potential Water Generator株式会社アルテックClass II
Dental Unit and ChairTakara Belmont CorporationClass II
Ultrasonic Bladder ScannerVitacon ASClass II
Test Cable KitMedtronic Inc.Class II
Alinity i STAT Myoglobin CalibratorsAbbott Ireland Diagnostics DivisionClass II
QUANTA Flash Calprotectin ControlsINOVA Diagnostics, Inc.Class II
Cyclosporine CalibratorsAbbott Ireland Diagnostics DivisionClass II
IPS Style Ceram and IPS IvocolorIvoclar Vivadent AGClass II
Alginate impression materials for dental useSAN ESU GYPSUM Co., LtdClass II
Y-Connector SetGenoss Co.,Ltd.Class II
Sources: NMPA