NMPA New Approvals In December2023


In December 2023, NMPA approved 343 medical devices, including 37 Class III imported products, 38 Class II imported products, and 266 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 December 2023.

Medical Device/IVDManufacturerCategory
DG Reader NetDiagnostic Grifols, S.A.Class III
Implantable pacemakersSt. Jude Medical Cardiac Rhythm Management DivisionClass III
Implantable Sacral Neurostimulation LeadMedtronic Inc.Class III
IV FiltersPall Medical, a Division of Pall International SàrlClass III
Polydioxanone sutureSearch Medical Co., Ltd.Class III
Trimark Breast Tissue MarkerHologic, Inc.Class III
TRUSELECT MicrocatheterBoston Scientific CorporationClass III
Modified Sodium Hyaluronate Gel for Injection with LidocaineYooYoung Pharmaceutical Co., Ltd.Class III
MitraClip G4 Clip Delivery SystemAbbott MedicalClass III
Coronary Intervention Control SystemRobocath S.A.SClass III
Implantable Cardioverter DefibrillatorCardiac Pacemakers, Inc., a subsidiary of Boston Scientific CorporationClass III
ArtiSential Multi-joint Laparoscopic Electrosurgical InstrumentsLivsMed Inc.Class III
Ophthalmic Nd:YAG laser treatment machine株式会社ニデックClass III
Implantable Cardioverter DefibrillatorCardiac Pacemakers, Inc., a subsidiary of Boston Scientific CorporationClass III
NEO IrisImmucor Medizinische Diagnostik GmbHClass III
Precision7 Soft Contact LensesAlcon Laboratories, Inc.Class III
Contrast Injector Hose Systemulrich GmbH & Co.KGClass III
PROLENE Polypropylene Nonabsorbable suture with PledgetEthicon, LLCClass III
PROLENE Polypropylene Nonabsorbable Suture with PledgetEthicon, LLCClass III
GUIDESTAR Steerable Guiding SheathOscor Inc.Class III
Meniscal Repair Device – FiberStitchT.A.G. Medical Products Corporation Ltd.Class III
MitraClip G4 Steerable Guide CatheterAbbott MedicalClass III
Arthrex SutureArthrex, Inc.Class III
PreciControl HBsAg Auto ConfirmRoche Diagnostics GmbHClass III
MammaTyper®BioNTech Diagnostics GmbHClass III
Vesta ChargerImpulse Dynamics (USA), Inc.Class III
Blood Parameter Monitoring SystemTerumo Cardiovascular Systems CorporationClass III
X-ray Angiography SystemSiemens Healthcare GmbHClass III
Implantable Cardioverter DefibrillatorCardiac Pacemakers, Inc., a subsidiary of Boston Scientific CorporationClass III
ICP Sensor KitsIntegra LifeSciences Production CorporationClass III
TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc.Class III
ILLUMISITE Endobronchial Procedure KitCovidien llcClass III
Dental ImplantNobel Biocare ABClass III
Proton Therapy SystemVarian Medical Systems Particle Therapy GmbH & Co. KGClass III
HemosIL Special Test Control Level 2Instrumentation Laboratory CompanyClass III
HemosIL Special Test Control Level 1Instrumentation Laboratory CompanyClass III
Helioseal F PlusIvoclar Vivadent AGClass II
PreludeSYNC DISTAL™ Radial Compression DeviceMerit Medical Systems,Inc.Class II
anti-caries gel(주) 해림덴텍Class II
Light-curing temporary restorative materialIvoclar Vivadent AGClass II
Glucose QC(주)올메디쿠스Class II
Alinity i STAT CK-MB Reagent KitAbbott Ireland Diagnostics DivisionClass II
Alinity i STAT CK-MB CalibratorsAbbott Ireland Diagnostics DivisionClass II
Ophthalmic Image Management Software株式会社トプコンClass II
SpyGlass Retrieval BasketBoston Scientific CorporationClass II
CoreDx Pulmonary Mini-ForcepsBoston Scientific CorporationClass II
UNIUM & ACRION Saw BladesGebr. Brasseler GmbH & Co. KGClass II
Zirconia Ceramic BlocksVITA Zahnfabrik H. Rauter GmbH & Co. KGClass II
SpyGlass Discover Digital ControllerBoston Scientific CorporationClass II
D-10 Hemoglobin Testing SystemBio-Rad Laboratories, Inc.Class II
HemosIL D-Dimer HS 500 ControlsInstrumentation Laboratory CompanyClass II
Endoscopes and AccessoriesMedos International SARLClass II
Dental unitDIPLOMAT DENTAL s.r.o.Class II
Damon Ultima BracketOrmco CorporationClass II
Cancer Antigen CA125 Calibrator東ソー株式会社Class II
InMotion ARMBionik,Inc.Class II
Ophthalmic Surgical Microscope株式会社タカギセイコーClass II
Tina-quant β2-Microglobulin(B2MG)Roche Diagnostics GmbHClass II
SpyGlass Discover Digital CatheterBoston Scientific CorporationClass II
Cannula GUroViu CorporationClass II
PFM alloyThe Argen CorporationClass II
Automatic Blood and Body Fluid Analyzerシスメックス株式会社Class II
Lupus CRoche Diagnostics GmbHClass II
Medical device imaging software in the clinical domain of cardiologyADAS3D Medical S.L.Class II
Chromatic VRELiofilchem S.r.l.Class II
Alinity c Fructosamine Calibrator KitSENTINEL CH. S.p.A.Class II
Squamous Cell Carcinoma (SCC)Siemens Healthcare Diagnostics Inc.Class II
Alinity i Anti-Tg CalibratorsAbbott Ireland Diagnostics DivisionClass II
Alinity i Anti-TPO CalibratorsAbbott Ireland Diagnostics DivisionClass II
Alinity i Anti-Tg Reagent KitAbbott Ireland Diagnostics DivisionClass II
Disposable Scissor Pliersオリンパスメディカルシステムズ株式会社Class II
Arthroscopy InstrumentsDePuy MitekClass II
Sources: NMPA