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/IVD	Manufacturer	Category
CharmCore Cement	Dentkist Inc.	Class III
iBrite Tooth Whitening Gel	Pac-Dent, Inc.	Class III
Disposable blunt end injection needle	Feel Tech Co.,Ltd.	Class III
Single use blood cell separator	Terumo BCT Ltd.	Class III
Custom Abutment	ARUM DENTISTRY Co., Ltd.	Class III
VACUETTE®QUICKSHIELD Complete/Complete Plus	Greiner Bio-One GmbH	Class III
Fluidfilter	東レ株式会社	Class III
TrailBlazer Angled Support Catheter	ev3, Inc.	Class III
MRI System	Siemens Healthcare GmbH	Class III
Cochlear Implant	Advanced Bionics AG	Class III
Cayenne Suture Anchors	Cayenne Medical, Inc.	Class III
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System	W.L. Gore & Associates, Inc.	Class III
Xpert® HBV Viral Load	Cepheid AB	Class III
Disposable high-frequency closed cutting surgical instrument	Covidien llc	Class III
Mammographic X-ray system	GE MEDICAL SYSTEMS SCS	Class III
Breast X-ray biopsy positioning system	Hologic, Inc	Class III
Free protein s determination kit (immunoturbidimetry)	DIAGNOSTICA STAGO	Class III
Disposable non absorbable closure clip	META BIOMED CO.,LTD	Class 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 anchor	Smith & Nephew Inc., Endoscopy Division	Class III
AXS Catalyst Distal Access Catheter	Stryker Neurovascular	Class III
PTA Catheter	Cordis Cashel	Class III
Dental implant system	Alpha-Bio Tec Ltd.	Class III
Hip Joint Prostheses-Acetabular Liner	Zimmer Inc.	Class III
Rigid breathable contact lens for corneal shaping	Menicon B.V.	Class III
Disposable nonabsorbable ligature clips	Teleflex Medical	Class III
CARDIAC POC Troponin T Control	Roche Diagnostics GmbH	Class II
X-ray flat panel detection system	キヤノン株式会社	Class II
MEDRAD Centargo CT Injection System	Imaxeon Pty Ltd	Class II
BODY COMPOSITION ANALYZER	SELVAS Healthcare, Inc.	Class II
GIA Autosuture Universal Stapler	Covidien llc	Class II
Guiding instrument for intrauterine endoscopy	AMNOTEC International Medical GmbH	Class II
Surgical Instruments for Endoscope	Elliquence, LLC.	Class II
X-ray Tube Assembly	FUJIFILM Healthcare Corporation	Class II
RAPIDPoint® 500e Blood Gas System	Siemens Healthcare Diagnostics Inc.	Class II
Alanine aminotransferase aspartate aminotransferase complex assay dry tablets (rate method / rate method)	Ortho-Clinical Diagnostics, Inc.	Class II
Spinal Endoscope	Elliquence, LLC.	Class II
Sterile balloon augmentation pressure pump	Seawon 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 film	HansBiomed Corp.	Class II
power system	ConMed Corporation	Class II
Sinus endoscopy	SCHÖLLY FIBEROPTIC GMBH	Class II
Fluorimetric immunoassay analyser（FIA）	Boditech Med Inc.	Class II
Fibrin (ogen) degradation product assay kit (immunoturbidimetry)	SYSMEX CORPORATION	Class II
B-type natriuretic peptide (BNP) assay kit	Tosoh Corporation	Class II
Device for Quality Assurance of Radiation Therapy	Standard Imaging, Inc.	Class II
Single use ophthalmic scalpel	マニー株式会社	Class II
Bone Grafting Material tool kits	Zimmer Knee Creations	Class II
Hydrocolloid waterproof band aid	3M Company	Class II
High sensitivity troponin I Assay Kit (microparticle chemiluminescent immunoassay)	Siemens Healthcare Diagnostics Inc.	Class II
Cold and hot therapeutic apparatus	DeRoyal Industries, Inc.	Class II

Sources: NMPA

NMPA New Approvals In June 2022

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