NMPA New Approvals In July 2023


In July 2023, NMPA approved 197 medical devices, including 21 Class III imported products, 21 Class II imported products, and 150 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 July 2023.

Medical Device/IVDManufacturerCategory
Dental ImplantDentis Co.,Ltd.Class III
Dual Mobility Vivacit-E Polyethylene Hip BearingZimmer Inc.Class III
Clearlab eyedia multi-purpose solutionClearlab SG Pte. Ltd.Class III
NovaSure Impedance Controlled Endometrial Ablation SystemHologic, Inc.Class III
Endoskeleton TCS Interbody SystemMedtronic Sofamor Danek USA, Inc.Class III
Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.Class III
Persona Trabecular Metal Knee SystemZimmer Inc.Class III
SP-CL Hip Stem ProsthesisWaldemar Link GmbH & Co.KGClass III
CP-MonitorSpiegelberg(GmbH&Co)KGClass III
Opalescence Endo Endodontic Whitening SystemUltradent Products, Inc.Class III
ROSA Recon PlatformZimmer CASClass III
Comprehensive Reverse Shoulder SystemZimmer Inc.Class III
Medical System for Ultrasound DiagnosisCompumedics Germany GmbHClass III
NeuroSpeed PTA Balloon CatheterAcandis GmbHClass III
AcrySof™ IQ Vivity™ Toric Extended Vision IOLAlcon Laboratories, IncorporatedClass III
Self-curing general purpose adhesive for dental gum adhesives株式会社トクヤマデンタルClass III
Holmium (Ho:YAG) laser therapy machineLumenis LimitedClass III
Ozone GeneratorsDr.J.Hansler GmbHClass III
Infusion Syringe PumpB. Braun Melsungen AGClass III
Diacan FlexB.Braun Avitum AGClass III
Preloaded System Intraocular LensHOYA Medical Singapore Pte. Ltd.Class III
Surgical Saw BladeZimmer Surgical, Inc.Class II
Sterile Nitrile Examination GloveHartalega Sdn. Bhd.Class II
Metal Self-ligating bracketAmerican OrthodonticsClass II
MicroScan Pos Combo Panel Type 44Beckman Coulter, Inc.Class II
Tina-quant Soluble Transferrin Receptor II(STFR2)Roche Diagnostics GmbHClass II
Line Polarized Light Pain Therapy東京医研株式会社Class II
Mick Applicator SystemMick Radio-Nuclear Instruments,Inc.Class II
Sof-Tray SheetsUltradent Products, Inc.Class II
Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical SolutionsClass II
Guide drills for dental implant systemPointNix Co.,Ltd.Class II
ElisaRSR™ IA-2 Ab Version 2RSR LimitedClass II
Ultra-clean bench for in vitro fertilizationASTEC CO.,LTD.Class II
Electronic Biliary Endoscopyオリンパスメディカルシステムズ株式会社Class II
ENT MR8 ClearViewMedtronic Powered Surgical SolutionsClass II
PHOTO THERMOLYSIS DEVICEActive Optical Systems Ltd.Class II
Low Frequency Combination StimulatorTRYCAM TECHNOLOGY CO.,LTD.Class II
Factor II Assay Kit (Coagulation Method)Roche Diagnostics GmbHClass II
Single-use Lens Injection SystemODC IndustriesClass II
POLYAMID monofilament non absorbable sterile surgical sutureTH. KAZANTZIDIS S.A. – MEDIPACClass II
Sources: NMPA