NMPA New Approvals In October2023


In October 2023, NMPA approved 221 medical devices, including 28 Class III imported products, 16 Class II imported products, and 176 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 October 2023.

Medical Device/IVDManufacturerCategory
Pre-milled Abutment BlanksInstitut Straumann AGClass III
Clareon Toric Aspheric Hydrophobic Acrylic IOLAlcon Laboratories, IncorporatedClass III
Rist™ Radial Access Selective CatheterMicro Therapeutics, Inc. DBA ev3 NeurovascularClass III
Oil for Embryo CultureFUJIFILM Irvine Scientific, Inc.Class III
Medizinische LaserAsclepion Laser Technologies GmbHClass III
CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences (Ireland) LtdClass III
Coblation Halo WandArthroCare CorporationClass III
CDI H/S CuvetteTerumo Cardiovascular Systems CorporationClass III
TECNIS® Symfony Toric Extended Range of Vision IOLJohnson & Johnson Surgical Vision, Inc.Class III
Contiplex S 360, continuous peripheral nerve block catheter set with ultrasound-visible stimulation needlesB. Braun Melsungen AGClass III
MatrixWAVE MMF SystemSynthes GmbHClass III
X-ray equipment for computed tomographySiemens Healthcare GmbHClass III
Pruitt® Irrigation Occlusion CatheterLeMaitre Vascular, Inc.Class III
TransForm Occlusion Balloon CatheterStryker NeurovascularClass III
V-Loc 90 Absorbable Wound Closure DeviceCovidien llcClass III
PTCA Balloon CatheterGenoss Co., Ltd.Class III
Abutments and accessoriesAPEIRON DENTAL S.r.lClass III
BD Ultra-Fine™ 2nd Gen Pen NeedlesBecton Dickinson and CompanyClass III
Affinity NT Oxygenator with Balance Biosurface& Uncoated Cardiotomy/ Venous ReservoirMedtronic, Inc.Class III
Persona Personalized Knee System – Persona Ti-NidiumZimmer Inc.Class III
EZStart™ Interference ScrewConMed CorporationClass III
Custom Stable™ Rigid Gas Permeable Scleral Contact LensValley Contax Inc.Class III
Cardiopulmonary bypass in-line blood gas sensorTerumo Cardiovascular Systems CorporationClass III
Restoration ADM and MDM SystemsHowmedica Osteonics Corp.Class III
HANAROSTENT Intestinal StentM.I.Tech Co., Ltd.Class III
White Blood Cell SetFresenius Kabi AGClass III
UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.Class III
OVOIL HEAVY™ for covering of medium during IVF and micro-manipulation proceduresVitrolife Sweden ABClass III
Single-use clip deviceオリンパスメディカルシステムズ株式会社Class II
Tunneler KitMedtronic Inc.Class II
BTL-6000 Super Inductive SystemBTL Industries LimitedClass II
Cochlear Sound ProcessorCochlear LimitedClass II
Mobile Operating TableTRUMPF Medizin Systeme GmbH + Co. KGClass II
ENT MR8 high-speed drill systemMedtronic Powered Surgical SolutionsClass II
cobas pure e 402Roche Diagnostics GmbHClass II
FilBloc Permanent – Polypropylene monofilament, synthetic non-absorbable smooth or barbed ,self-retaining surgical suture, sterileAssut Europe S.p.A.Class II
Body Composition AnalyzerInBody Co., Ltd.Class II
Non-absorbable suturesEthicon, LLCClass II
Nasopharyngeal AirwayCovidien llcClass II
Semiconductor laser therapyTheradome Inc.Class II
Automatic Biochemistry AnalyzerRoche Diagnostics GmbHClass II
Sources: NMPA