NMPA New Approvals In November2023


In November 2023, NMPA approved 301 medical devices, including 34 Class III imported products, 39 Class II imported products, and 226 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 November 2023.

Medical Device/IVDManufacturerCategory
Proton Therapy SystemVarian Medical Systems Particle Therapy GmbH & Co. KGClass III
Amplatzer Talisman PFO OccluderAbbott MedicalClass III
Amplatzer Talisman Delivery SheathAbbott MedicalClass III
CONTACT LENSESSupervision Optimax Sdn BhdClass III
Arctic Sperm Cryopreservation MediumFUJIFILM Irvine Scientific, Inc.Class III
Anchored balloon dilatation catheter株式会社カネカClass III
Dual-curing bonding resin watermendTokuyama Dental CorporationClass III
SU-POR Patient-Specific Surgical ImplantPoriferous, LLCClass III
Sterile Silicone Breast Implants Motiva Implant MatrixEstablishment Labs S.A.Class III
ProTi360°Interbody SystemTyber Medical, LLCClass III
MP Monoblock Hip Prosthesis StemWaldemar Link GmbH & Co. KGClass III
ROTAPRO Rotational Atherectomy SystemBoston Scientific CorporationClass III
Diagnostic Ultrasound SystemGE Healthcare Austria GmbH & Co OGClass III
ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing DeviceBoston Scientific CorporationClass III
SPECT/CTSpectrum Dynamics Medical Ltd.Class III
Precision1 for Astigmatism soft contact lensesAlcon Laboratories, Inc.Class III
Clareon PanOptix Trifocal Hydrophobic IOLAlcon Laboratories, IncorporatedClass III
Continuous Single Culture® Complete (CSCM-C)FUJIFILM Irvine Scientific, Inc.Class III
Soft Tissue Implants Visco-elastic gel of hyaluronic acid – with lidocaineLaboratoires Fill-Med Manufacturing S.A.Class III
pORTAL Steerable Hydrophilic Guidewirephenox GmbHClass III
AngioSculpt PTCA Scoring Balloon Catheter, Rapid Exchange (RX)Philips Image Guided Therapy CorporationClass III
ACTIS DuoFix Hip ProsthesisDePuy (Ireland)Class III
ETHIBOND Excel Polyester Suture with PledgetEthicon, LLCClass III
3M Tegaderm High Performance Foam Non-Adhesive Dressing3M CompanyClass III
PEEK Suture AnchorArthrex, Inc.Class III
ETHIBOND Excel Polyester Suture with PledgetEthicon, LLCClass III
Continuous Glucose Monitoring SystemAbbott Diabetes Care Ltd.Class III
SpaceStation and SpaceComB. Braun Melsungen AGClass III
StarWalkerFotona d.o.o.Class III
cobas® 5800 InstrumentRoche Molecular Systems, Inc.Class III
Patient monitorGE Medical Systems Information Technologies, Inc.Class III
RGP ASPHERIC LensFitlens LtdClass III
Steerable guiding sheathOscor Inc.Class III
Accu-Chek Guide Link blood glucose meterRoche Diabetes Care GmbHClass II
Free Beta Human Chorionic Gonadotropin (FBHCG)Siemens Healthcare Diagnostics Inc.Class II
Pulse CO-OximeterMasimo CorporationClass II
Medical Images Processing SoftwareSiemens Healthcare GmbHClass II
Pregnancy-Associated Plasma Protein-A (PAPP-A)Siemens Healthcare Diagnostics Inc.Class II
Haptoglobin assay kit (Immunoturbidimetric method)Siemens Healthcare Diagnostics Inc.Class II
Liquichek Immunology ControlBio-Rad Laboratories, Inc.Class II
Squamous Cell Carcinoma Calibrator (SCC CAL)Siemens Healthcare Diagnostics Inc.Class II
N Protein Standard UYSiemens Healthcare Diagnostics Products GmbHClass II
Uriflet S 11UAARKRAY Factory, Inc.Class II
Video DuodenoscopeHOYA株式会社Class II
Ophthalmoscope Fundus CameraCenterVue S.p.A.Class II
Uro-3500 Display Handle KitUroViu CorporationClass II
Flexible Endoscope, Single-useAmbu A/SClass II
Disposable biopsy forcepsオリンパスメディカルシステムズ 株式会社Class II
CEREC TesseraDeguDent GmbHClass II
Attachmentsbredent GmbH & Co. KGClass II
Transnasal Feeding TubeFresenius Kabi AGClass II
Surgical Instrument KitMegaGen Implant Co.,Ltd.Class II
Electric Traction Chairオージー技研株式会社Class II
SleepImage SystemMyCardio LLCClass II
Diagnostic Ultrasound SystemGE Vingmed Ultrasound A/SClass II
Cholinesterase assay kit (butyrylthiocholine substrate method)Siemens Healthcare Diagnostics Inc.Class II
Battery Power Supply Surgical Equipment for Osseous TissueSynthes GmbHClass II
CalSet FT4 IVRoche Diagnostics GmbHClass II
Attachmentsbredent GmbH & Co. KGClass II
Dental Zirconia Porcelain Powder株式会社松風Class II
Bright ImpressGenoss Co., Ltd.Class II
Kangaroo Connect Enteral Feeding SetsCovidien llcClass II
Surgipro II Monofilament Polypropylene Nonabsorbable Suture with CARDIOPOINT Cardiovascular NeedlesCovidien llcClass II
Condensation Silicones for Dental ImpressionZHERMACK S.p.AClass II
Lupus SRoche Diagnostics GmbHClass II
FLUID CONTROL 2225Richard Wolf GmbHClass II
Acid Oxidation Potential Water Generatorアマノ株式会社Class II
myoelectric evoked potentials (EMG)日本光電工業株式会社Class II
Comprehensive Dental Treatment MachinesDentium Co., Ltd.Class II
Sources: NMPA