NMPA New Approvals In April 2022


In April 2022, NMPA approved 212 medical devices, including 35 Class III imported products, 20 Class II imported products, and 154 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 April, 2022.

Medical Device/IVDManufacturerCategory
Hydrophilic-coated intravascular angiography catheterTerumoClass III
Ticron Coated Braided Polyester Nonabsorbable SutureCovidien llcClass III
Safari²™ GuidewiresLake Region MedicalClass III
Healix Advance SP PEEK AnchorMedos International SARLClass III
Vantage Galan 3T MRT-3020CanonClass III
Peripheral Coil SystemMicroVention,Inc.Class III
Laparoscopic high-frequency surgical instrumentsGIMMI GmbHClass III
Implantable Cardioverter/DefibrillatorsMicroPort CRM S.r.l.Class III
Stellant Flex Disposable KitBayer Medical Care Inc.Class III
SCENARIA ViewFuji FilmClass III
Dermalax DeepACROSS CO., LTD.Class III
Collagen-based dental bone filling materialGENOSS Co., Ltd.Class III
Triathlon Tritanium Knee SystemHowmedica Osteonics Corp.Class III
True Form Reshapable Guide WireMerit Medical Systems, Inc.Class III
Tubing systems for Continuous Blood purificationFresenius Medical Care AG & Co. KGaAClass III
GO2 Steerable Guide Wire SystemMerit Medical Systems,Inc.Class III
Disposable blunt tip needle(주)제일테크Class III
HydroSoft 3D Embolic SystemMicroVention, Inc.Class III
INDIGO Aspiration SystemPenumbra, Inc.Class III
Fresenius HD-Tubing systemsFresenius Medical Care AG & Co. KGaAClass III
Tubing Systems for Continuous Blood PurificationFresenius Medical Care AG & Co. KGaAClass III
Orthophos S 3DSirona Dental Systems GmbHClass III
Resectoscope accessoriesSTEMA Medizintechnik GmbHClass III
Hemodynamic and Electrophysiological Recording SystemSiemens Healthcare GmbHClass III
20223130205NeoTract, Inc.Class III
Dental ImplantNobel Biocare ABClass III
CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.Class III
ACUVUE® VITA™ Brand Contact Lenses for ASTIGMATISMJohnson & Johnson Vision Care,Inc.Class III
Fracture and Correction SystemIn2Bones USAClass III
ABT12 multi-purpose solutionBausch & Lomb IncorporatedClass III
Resection endoscopes and accessoriesGIMMI GmbHClass III
Ultrasound Diagnostic EquipmentSAMSUNG MEDISON CO., LTD.Class III
Aptima HIV-1 Quant Dx AssayHologic, Inc.Class III
Lumipulse® G Pepsinogen IIFujirebio Inc.Class III
Erythropoietin (EPO) Quality ControlSiemens Healthcare Diagnostics Inc.Class II
Lumipulse® ProGRP ControlsFujirebio Inc.Class II
3D OCT-1 Maestro2TopconClass II
Ambu aView MonitorAmbu A/SClass II
Total Bile AcidsSENTINEL CH. S.p.A.Class II
Therapy MonitorFresenius Medical Care AG & Co. KGaAClass II
Rifampicin Susceptibility Test DiscOxoid LimitedClass II
Amoxycillin/Clavulanic Acid Susceptibility Test DiscOxoid LimitedClass II
Surgical MicroscopeLeica Microsystems (Schweiz) AGClass II
Vitamin D total II CalSetRoche Diagnostics GmbHClass II
CONTOUR CARE blood glucose meterAscensia Diabetes Care Holdings AGClass II
EUROArrayScannerEUROIMMUN Medizinische Labordiagnostika AGClass II
Acrobat® 2 Calibrated Tip Wire GuideWilson-Cook Medical, Inc.Class II
Primescan ACSirona Dental Systems GmbHClass II
Androstenedione (ANDRO)Siemens Healthcare Diagnostics Inc.Class II
The F1 Battery Powered Micro systemStryker InstrumentsClass II
SpyScope DS II Access and Delivery CatheterBoston Scientific CorporationClass II

Sources: NMPA