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)
