NMPA New Approvals In January 2023


2023-02-16

In January 2023, NMPA approved 124 medical devices, including 11 Class III imported products, 12 Class II imported products, and 99 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 January 2023.

Medical Device/IVDManufacturerCategory
Cardiac Resynchronization Device Tiered-therapy Cardioverter/DefibrillatorSt. Jude Medical Coordination Center BVBAClass III
Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.Class III
BD Vacutainer® Safety-Lok™ Blood Collection SetBecton Dickinson and CompanyClass III
Belotero Volume LidocaineAnteis SAClass III
Athletis OVER-THE-WIRE PTA Balloon Dilatation CatheterBoston Scientific CorporationClass III
Restylane VolymeQ-Med ABClass III
TiBases and ScrewsZfx GmbHClass III
Medical X-Ray angiography equipmentGE MEDICAL SYSTEMS SCSClass III
Diagnostic Ultrasound SystemESAOTE S.p.A.Class III
Ultrasound Diagnostic EquipmentSUPERSONIC IMAGINEClass III
Cardiac Resynchronization Device Tiered-therapy Cardioverter/DefibrillatorSt.Jude Medical Coordination Center BVBAClass III
Dissecting ToolsMedtronic Powered Surgical SolutionsClass II
Riptide™ Large Bore Aspiration TubingMicro Therapeutics, Inc.DBA ev3 NeurovascularClass II
Vertebroplasty AdjunctsSeawon Meditech Co., Ltd.Class II
Subcyclo ProbeQUANTEL MEDICALClass II
HDL Cholesterol Calibrator (HDLC CAL)Siemens Healthcare Diagnostics Inc.Class II
QUANTA-Lyser 3000 ELISA/IFA + IncubatorINOVA Diagnostics, Inc.Class II
Automatic air mattress systemsCare of Sweden ABClass II
Mobile ECG Atrial Fibrillation Alert Software삼성전자(주)Class II
Wrist0x2 Pulse 0ximeterNonin Medical,Inc.Class II
Diagnostic X-Ray tubeVAREX IMAGING CORPORATIONClass II
Skater FixArgon Medical Devices, Inc.Class II
Aqua Maris® Strong nasal sprayJadran-Galenski laboratorij d.d.Class II
Sources: NMPA