NMPA New Approvals In June 2022


In June 2022, NMPA approved 193 medical devices, including 26 Class III imported products, 25 Class II imported products, and 139 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 June, 2022.

Medical Device/IVDManufacturerCategory
CharmCore CementDentkist Inc.Class III
iBrite Tooth Whitening GelPac-Dent, Inc.Class III
Disposable blunt end injection needleFeel Tech Co.,Ltd.Class III
Single use blood cell separatorTerumo BCT Ltd.Class III
Custom AbutmentARUM DENTISTRY Co., Ltd.Class III
VACUETTE®QUICKSHIELD Complete/Complete PlusGreiner Bio-One GmbHClass III
Fluidfilter東レ株式会社Class III
TrailBlazer Angled Support Catheterev3, Inc.Class III
MRI SystemSiemens Healthcare GmbHClass III
Cochlear ImplantAdvanced Bionics AGClass III
Cayenne Suture AnchorsCayenne Medical, Inc.Class III
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL SystemW.L. Gore & Associates, Inc.Class III
Xpert® HBV Viral LoadCepheid ABClass III
Disposable high-frequency closed cutting surgical instrumentCovidien llcClass III
Mammographic X-ray systemGE MEDICAL SYSTEMS SCSClass III
Breast X-ray biopsy positioning systemHologic, IncClass III
Free protein s determination kit (immunoturbidimetry)DIAGNOSTICA STAGOClass III
Disposable non absorbable closure clipMETA BIOMED CO.,LTDClass III
FluidiTube 2.7F Infusion Micro Catheterテルモ・クリニカルサプライ株式会社Class III
No knot anchorSmith & Nephew Inc., Endoscopy DivisionClass III
AXS Catalyst Distal Access CatheterStryker NeurovascularClass III
PTA CatheterCordis CashelClass III
Dental implant systemAlpha-Bio Tec Ltd.Class III
Hip Joint Prostheses-Acetabular LinerZimmer Inc.Class III
Rigid breathable contact lens for corneal shapingMenicon B.V.Class III
Disposable nonabsorbable ligature clipsTeleflex MedicalClass III
CARDIAC POC Troponin T ControlRoche Diagnostics GmbHClass II
X-ray flat panel detection systemキヤノン株式会社Class II
MEDRAD Centargo CT Injection SystemImaxeon Pty LtdClass II
GIA Autosuture Universal StaplerCovidien llcClass II
Guiding instrument for intrauterine endoscopyAMNOTEC International Medical GmbHClass II
Surgical Instruments for EndoscopeElliquence, LLC.Class II
X-ray Tube AssemblyFUJIFILM Healthcare CorporationClass II
RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.Class II
Alanine aminotransferase aspartate aminotransferase complex assay dry tablets (rate method / rate method)Ortho-Clinical Diagnostics, Inc.Class II
Spinal EndoscopeElliquence, LLC.Class II
Sterile balloon augmentation pressure pumpSeawon Meditech Co., Ltd.Class II
Disposable endoscopic ultrasonic biopsy needleオリンパスメディカルシステムズ株式会社Class II
Dressing fluid-impermeable filmHansBiomed Corp.Class II
power systemConMed CorporationClass II
Fluorimetric immunoassay analyser(FIA)Boditech Med Inc.Class II
Fibrin (ogen) degradation product assay kit (immunoturbidimetry)SYSMEX CORPORATIONClass II
B-type natriuretic peptide (BNP) assay kitTosoh CorporationClass II
Device for Quality Assurance of Radiation TherapyStandard Imaging, Inc.Class II
Single use ophthalmic scalpelマニー株式会社Class II
Bone Grafting Material tool kitsZimmer Knee CreationsClass II
Hydrocolloid waterproof band aid3M CompanyClass II
High sensitivity troponin I Assay Kit (microparticle chemiluminescent immunoassay)Siemens Healthcare Diagnostics Inc.Class II
Cold and hot therapeutic apparatusDeRoyal Industries, Inc.Class II
Sources: NMPA