In April 2023, NMPA approved 180 medical devices, including 21 Class III imported products, 33 Class II imported products, and 125 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 2023.
| MedicalDevice/IVD | Manufacturer | Category |
| COLTRIXCartiRegen | UbiosisCo.,Ltd | ClassIII |
| SigniaSmallDiameterReloads | Covidienllc | ClassIII |
| FunctionalNeurosurgeryElectrophysiology RecordingSystem | AlphaOmegaEngineeringLtd. | ClassIII |
| CR-typecatheter | FCareSystemsNV | ClassIII |
| PersonaPartialKneeSystem | BiometOrthopedics | ClassIII |
| TECNIS®1-PieceIOLwithTECNIS Simplicity™DeliverySystem | Johnson&JohnsonSurgicalVision,Inc. | ClassIII |
| Pulsar-18T3PeripheralSelf-expanding NitinolStentSystem | BIOTRONIKAG | ClassIII |
| ElecsysPIVKA-II | RocheDiagnosticsGmbH | ClassIII |
| AcrySof™IQVivity™ExtendedVision IntraocularLens(IOL) | AlconLaboratories,Incorporated | ClassIII |
| AperioHybridThrombectomyDevice | AcandisGmbH | ClassIII |
| CONDUIT™InterbodyCages | EmergingImplantTechnologiesGmbH | ClassIII |
| PrismaflexTPESet | GambroIndustries | ClassIII |
| A-Viearchee | SCLCO.,LTD. | ClassIII |
| BiatainSiliconeNon-BorderFoamDressing | ColoplastA/S | ClassIII |
| NautilusSmartECMOModule | MC3Inc. | ClassIII |
| 3DprintedRedaptModularAcetabular System | Smith&Nephew,Inc. | ClassIII |
| CompressionScrew | Arthrex,Inc. | ClassIII |
| DentalImplants | APEIRONDENTALS.r.l. | ClassIII |
| ComprehensiveFractureShoulderSystem | BiometOrthopedics | ClassIII |
| PICO14SingleUseNegativePressure WoundTherapySystem | Smith&NephewMedicalLimited | ClassIII |
| SafetyPenNeedle | OwenMumfordLimited | ClassIII |
| ControlSetsTfRII | RocheDiagnosticsGmbH | ClassII |
| HITACHIISECONTROL(LIQUID) | HitachiHigh-TechCorporation | ClassII |
| ProxeoTWISTPolishingSystem | W&HDentalwerkBürmoosGmbH | ClassII |
| VITROSXTChemistryProductsUREA-CREA Slides | Ortho-ClinicalDiagnostics,Inc. | ClassII |
| PulseOximeter | MasimoCorporation | ClassII |
| ExtractionBalloonCatheter | ゼオンメディカル株式会社 | ClassII |
| Sterileseawaterinvialsfornasal cavitiescleansing | LABORATOIREUNITHER | ClassII |
| directCheckNormalControls-ACT | AccrivaDiagnostics,Inc. | ClassII |
| LDLCholesterol | SiemensHealthcareDiagnosticsInc. | ClassII |
| LDLCholesterolCalibrator | SiemensHealthcareDiagnosticsInc. | ClassII |
| Amylase_2(AMY_2) | SiemensHealthcareDiagnosticsInc. | ClassII |
| SmallBoneCuttingAccessories | StrykerInstruments | ClassII |
| EsTempNENon-EugenolTemporaryCement | SPIDENTCo.,Ltd. | ClassII |
| LMAUniqueTM(SiliconeCuff)&LMA UniqueTM(SiliconeCuff)CuffPilotTM | TeleflexMedical | ClassII |
| Active-B12(Holotranscobalamin)(AB12) | SiemensHealthcareDiagnosticsInc. | ClassII |
| Ureteroscope&Accessories | OlympusWinter&IbeGmbH | ClassII |
| SingleUseSterileOpticalFiber | G.N.SneoLaserLtd. | ClassII |
| ManualWheelchair | RGKWheelchairsLtd. | ClassII |
| Shockwavetherapydevice | （주）웨버인스트루먼트 | ClassII |
| FlipCutterIII | T.A.G.MedicalProductsCorporationLtd. | ClassII |
| DisposableinstrumentsofREAL INTELLIGENCECORI | BlueBeltTechnologies，Inc. | ClassII |
| EliteLXBoneCuttingAccessories | StrykerInstruments | ClassII |
| OpticalCoherenceTomography | キヤノン株式会社 | ClassII |
| BiZactTonsillectomyDeviceAdvanced BipolarTissueSealer/Divider | Covidienllc | ClassII |
| 3MCavilonAdvancedSkinProtectant | 3MCompany | ClassII |
| KangarooConnectEnteralFeedingSets | Covidienllc | ClassII |
| DisposableBackflushinstruments | D.O.R.C.DutchOphthalmicResearchCenter(International)B.V. | ClassII |
| Active-B12(AB12)QualityControl | SiemensHealthcareDiagnosticsInc. | ClassII |
| HDLCholesterol(HDLC) | SiemensHealthcareDiagnosticsInc. | ClassII |
| MicroScanPosMICPanelType34 | BeckmanCoulter,Inc. | ClassII |
| Endoscopiccameraequipment | GIMMIGmbH | ClassII |
| LC-MS/MSSystem | ABSciexPte.Ltd. | ClassII |
| LithiumSilicateGLASSCERAMICS | 而至株式会社（株式会社ジーシー） | ClassII |
Sources: NMPA
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