NMPA New Approvals In November 2022

2023-01-04

In November 2022, NMPA approved 172 medical devices, including 22 Class III imported products, 29 Class II imported products, and 121 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 November, 2022.

Medical Device/IVD	Manufacturer	Category
DURAFIBER Ag	Smith & Nephew Medical Ltd	Class III
Passeo-35 Xeo Peripheral Dilatation Catheter	BIOTRONIK AG	Class III
Infiniti Angiographic Catheter	Cordis Corporation	Class III
LCU Cemented Hip Prosthesis Stem	Waldemar Link GmbH & Co. KG	Class III
HEALON PRO, Sterile Viscoelastic Solution for Intraocular Use	AMO Uppsala AB	Class III
REGENETEN Bioinductive Implant System Gen 3.5	Smith&Nephew Inc. Endoscopy Division	Class III
Single use blood dialyzers	Gambro Dialysatoren GmbH	Class III
QDOT Micro Diagnostic/Ablation Deflectable Tip Catheter	Biosense Webster (Israel) Ltd.	Class III
Infusion tubing set	AMPALL CO.,Ltd	Class III
Peritoneal Dialysis Catheter	Covidien llc	Class III
Calcium Line-CA250	Baxter Healthcare SA	Class III
SAFETY Blood Collection Sets	Greiner Bio-One GmbH	Class III
Resolute Onyx Zotarolimus-Eluting Coronary Stent System	Medtronic, Inc.	Class III
Tria Soft Ureteral Stent	Boston Scientific Corporation	Class III
EmboTrap III Revascularization System	Neuravi Limited	Class III
ENSEAL X1 Tissue Sealer	Ethicon Endo – Surgery, LLC	Class III
Journey II Unicompartmental Knee System	Smith & Nephew, Inc.	Class III
RapidWarm™ Omni media for warming	Vitrolife Sweden AB	Class III
Continuous Compression Implants	Synthes GmbH	Class III
Mammotome Revolve EX Ultrasound Probe	Devicor Medical Products, Inc.	Class III
HemosIL Low Abnormal Control Assayed	Instrumentation Laboratory Company	Class III
Vectus Laser System	Candela Corporation	Class III
Hysteroscopy	DELMONT IMAGING	Class II
Ultrasonic Diagnostic System	ESAOTE S.p.A.	Class II
Clinician Programmer	Medtronic Inc.	Class II
Slit lamp	Carl Zeiss Meditec AG	Class II
ASONOR	TannerMedico A/S	Class II
Adhesive and conductive cream	SPES MEDICA S.R.L.	Class II
Single use arthroscopic abrasive head	(주)엔도비전	Class II
Electronic lower gastrointestinal endoscopy	富士フイルム株式会社	Class II
HISCL KL-6 Calibrator	SEKISUI MEDICAL CO., LTD.	Class II
Optometry aggregometer	株式会社レクザム	Class II
Tonometer	Icare Finland Oy	Class II
Tyto Stethoscope	Tyto Care Ltd.	Class II
Software for Dental Implant Surgery Planning	Dentium Co., Ltd.	Class II
Mako Ball Burr	MAKO Surgical Corp.	Class II
REMOVER	MICRO-MEGA SA	Class II
Retraction Cord	GINGI-PAK a division of The Belport Co.,Inc.	Class II
Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL)	Siemens Healthcare Diagnostics Inc.	Class II
Powered Suction Pump	Stryker Instruments	Class II
GreenLight HPS Laser Fiber	Boston Scientific Corporation	Class II
CONTOUR NEXT (Connected) blood glucose meter	Ascensia Diabetes Care Holdings AG	Class II
Automated Blood Coagulation Analyzer	SYSMEX CORPORATION	Class II
Automated Blood Coagulation Analyzer	SYSMEX CORPORATION	Class II
Navios EX Flow Cytometer	Beckman Coulter Ireland, Inc.	Class II
VIDEO NASO-PHARYNGO-LARYNGOSCOPE	HOYA	Class II
Neuroline Subdermal Needle Electrode and Neuroline Twisted Pair Subdermal Needle Electrode	Ambu A/S	Class II
X-ray flat panel detection system	Vieworks Co.,Ltd.	Class II
Laser Positioning Systems	LAP GmbH Laser Applikationen	Class II
AMSCO 7052HP Single-Chamber Washer/Disinfector	STERIS Corporation	Class II
Upper extremity rehabilitation training system	Tyromotion GmbH	Class II