NMPA New Approvals In September 2023


In September 2023, NMPA approved 187 medical devices, including 25 Class III imported products, 24 Class II imported products, and 137 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 September 2023.

Medical Device/IVDManufacturerCategory
Ultrascore Focused Force PTA BalloonBard Peripheral Vascular, Inc.Class III
IntraCorporal Lithotripters systemsE.M.S. Electro Medical Systems S.A.Class III
Tri-Staple™ 2.0 Reinforced ReloadCovidien llcClass III
AquaBeam Robotic SystemPROCEPT BioRobotics CorporationClass III
Peripheral Coil SystemMicroVention, Inc.Class III
ENTACT Septal StaplerArthroCare CorporationClass III
JuggerStitch Meniscal Repair DevicesBiomet Sports MedicineClass III
Saber.035 PTA Dilatation CatheterCordis CorporationClass III
AngioSculpt PTA Scoring Balloon CatheterSpectranetics CorporationClass III
NeuroBridge A70 CatheterAcandis GmbHClass III
Intraocular LensLenstec (Barbados) Inc.Class III
SafeSheath II Hemostatic Tear-away IntroducerOSCOR INC.Class III
RF Treatment SystemCynosure, LLCClass III
Protein C ChromRoche Diagnostics GmbHClass III
Monarch BronchoscopeAuris Health, Inc.Class III
Monarch PlatformAuris Health, Inc.Class III
Abutment and AccessoriesDentium Co., Ltd.Class III
Bioceramic root canal sealerMETA BIOMED CO., LTD.Class III
Dental Implant SystemMIS Implants Technologies Ltd.Class III
RF20000 Werewolf Coblation SystemArthroCare CorporationClass III
Extracorporeal Shockwave LithotripterDornier MedTech GmbHClass III
DiamondTemp Ablation SystemMedtronic, Inc.Class III
DiamondTemp Ablation CatheterMedtronic, Inc.Class III
Implantable Pacing LeadMedtronic, Inc.Class III
UltraCor Twirl Breast Tissue MarkerBard Peripheral Vascular, Inc.Class III
AXS Infinity LS PlusStryker NeurovascularClass II
Injection Cannula KitMöller Medical GmbHClass II
FV Assay Kit (Coagulation Method)Roche Diagnostics GmbHClass II
ChemWell®FUSION also known as Project 4800 ELISA & CLIA AnalyzerAwareness Technology, Inc.Class II
TRAb Reagent KitAbbott Ireland Diagnostics DivisionClass II
TRAb ControlsAbbott Ireland Diagnostics DivisionClass II
Elecsys AndrostenedioneRoche Diagnostics GmbHClass II
Single-use assisted lithotripterオリンパスメディカルシステムズ株式会社Class II
Tourniquet CuffsDelfi Medical Innovations Inc.Class II
NoCoding1 Plus Blood Glucose Monitoring Systemi-SENS, Inc.Class II
CIRRUS HD-OCTCarl Zeiss Meditec, Inc.Class II
Eurotrol epoc GAS-ISE MetabolitesEurotrol B.V.Class II
TECHNOPATH Multi-CHECK CardiacTechno-path Manufacturing LtdClass II
Dental Digital Imaging SoftwareCarestream Dental LLCClass II
Thyroglobulin CalibratorsAbbott GmbHClass II
Surgical lightBrandon Medical Company LimitedClass II
Assisted reproduction procedure dishGenea Biomedx Pty LtdClass II
4GEM ChemSTAT CVP 4Instrumentation Laboratory CompanyClass II
CL AIA-PACK Myoglobin TEST CUP東ソー株式会社Class II
Thyroglobulin Reagent KitAbbott GmbHClass II
Intraoral Optical Scanning System3Shape TRIOS A/SClass II
Battery Powered Bone Tissue Surgery DeviceOSTEONIC Co., Ltd.Class II
Regional Oximeter SystemMasimo CorporationClass II
Thyroglobulin ControlsAbbott GmbHClass II