NMPA New Approvals In June 2023


In June 2023, NMPA approved 264 medical devices, including 46 Class III imported products, 19 Class II imported products, and 198 Class III domestic products.

NMPA is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. 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 June 2023.

Medical Device/IVDManufacturerCategory
Coronary Interventional Surgical Control SystemCorindus Inc.Class III
CorPath GRX System AccessoriesCorindus Inc.Class III
Disposable Radio Frequency ( RF ) NeedlesSPECTRA MEDICAL DEVICES, INC.Class III
IntraSight Mobile SystemVolcano CorporationClass III
Synchro SELECT GuidewireStryker NeurovascularClass III
JuggerKnot/JuggerKnotless Soft AnchorBiomet Sports MedicineClass III
OCT Spinal Fixation SystemBricon GmbHClass III
TOTAL30 Soft Contact LensesAlcon Laboratories, Inc.Class III
Supera Peripheral Stent SystemAbbott VascularClass III
HEALICOIL Knotless Suture AnchorSmith & Nephew Inc., Endoscopy DivisionClass III
PowerPort ClearVUE™ ISP Implantable PortBard Access Systems, Inc.Class III
Total Knee System-Tibial insert and Patella Componentb-ONE Ortho, Corp.Class III
Micro Catheter朝日インテック株式会社Class III
TherMax Blood Warmer DisposableBaxter Healthcare SAClass III
Ophthalmic Intraoperative OCT systemCarl Zeiss Meditec AGClass III
Dual Pulsed Nd:YAG laserLutronic CorporationClass III
Delivery CatheterCenterPoint Systems LLCClass III
Dental Cone-beam Computed TomographyDentium Co., Ltd.Class III
LeonardoCeramOptec GmbHClass III
Coagpia Calibrator-NSEKISUI MEDICAL CO.,LTD.Class III
OptiBond eXTRa UniversalKerr CorporationClass III
Rigid scleral contact lensCapricornia Contact Lens Pty LtdClass III
Trevo NXT ProVue RetrieverStryker NeurovascularClass III
I.V. administration set, Type: UV-ProtectB. Braun Melsungen AGClass III
Implantable cardiac pacemakers with cardiac resynchronization therapyMedtronic Inc.Class III
PreXion3D Explorerブレキシオン株式会社Class III
Disposable Pressure TransducerEdwards Lifesciences LLCClass III
SpineJet Hydrosurgical handpieceHydroCision, Inc.Class III
ZAP-X Radiosurgery SystemZAP Surgical Systems, Inc.Class III
Patient Positioning SystemC-RAD Positioning ABClass III
Triathlon Partial Knee Resurfacing SystemHowmedica Osteonics Corp.Class III
Echelon Micro Catheter朝日インテック株式会社Class III
GORE TIPS SetCreganna MedicalClass III
Global Unite Shoulder SystemDePuy (Ireland)Class III
 Healix Advance BR with DynacordMedos International SARLClass III
LIAISON® Treponema ScreenDiaSorin S.p.A.Class III
LABScreen Single Antigen HLA Class II – Group 1One Lambda, Inc.Class III
LABScreen Single Antigen HLA Class I – CombiOne Lambda, Inc.Class III
Extracorporeal Bloodlines for Blood PurificationFresenius Medical Care AG & Co. KGaAClass III
M.blue(plus), single-use hydrostatic pressure, adjustable valve hydrocephalus shunt and components systemChristoph Miethke GmbH & Co. KGClass III
Form Fit® Hydrogel Canalicular PlugOASIS® Medical, Inc.Class III
R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.Class III
Flow Aspiration CatheterARTHESYSClass III
Truespan Meniscal Repair SystemMedos International SARLClass III
Penfine Classic pen needleテルモ株式会社Class III
GEM ChemSTAT CVP 2Instrumentation Laboratory CompanyClass II
Knee Joint InstrumentsZimmer Inc.Class II
PRG Barrier Coat株式会社松風Class II
Micromanipulation PipettesVitrolife Sweden ABClass II
Adult Esophageal Balloon Catheter SetCooperSurgical, Inc.Class II
Enzymatic Creatinine_2 Reagents (ECRE_2)株式会社 ナスカClass II
CL AIA-PACK CK-MB TEST CUPTosoh CorporationClass II
SmartLite Pro Modular LED Curing LightDENTSPLY LLCClass II
CareSens II Plus Blood Glucose Monitoring Systemi-SENS, Inc.Class II
Intelect RPW 2 SystemDJO FRANCE SASClass II
GEM ChemSTAT CVP 1Instrumentation Laboratory CompanyClass II
WILMO株式会社エスケーエレクトロニクスClass II
Natural Latex Rubber CondomPLEASURE LATEX PRODUCTS SDN. BHD.Class II
SoftPrep Root Canal Preparation EDTA CreamSPIDENT Co., Ltd.Class II
LIASAUTO Control 2シスメックス株式会社Class II
ArtiSential Multi-joint Endoscopic Surgical InstrumentsLivsMed Inc.Class II
LMA Flexible PreCurved&LAM Flexible PreCurved Cuff PilotTeleflex MedicalClass II
TRAb CalibratorsAbbott Ireland Diagnostics DivisionClass II
Sources: NMPA