In February 2024, NMPA approved 193 medical devices, including 21 Class III imported products, 22 Class II imported products, and 148 Class III domestic products.
China NMPA is constantly upgrading regulations and guidelines for medical device regulatory, clinical affairs and post market surveillance in latest years. BradyKnows elite team has extensive experiences to support the whole life cycle of medical device. 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 February 2024.
Medical Device/IVD
Manufacturer
Category
GentleMax Pro Plus
Candela Corporation
Class III
Composite QC level 2
東ソー株式会社
Class III
X-ray computed tomography equipment
GEヘルスケア・ジャパン株式会社
Class III
External Ventricular DrainageEconomic
HP BIOPROTESES LTDA
Class III
ACUVUE OASYS MAX 1-DAY Contact Lenses
Johnson & Johnson Vision Care, Inc.
Class III
PTCA guidewire
朝日インテック株式会社
Class III
Preloaded Intraocular Lens
HOYA Medical Singapore Pte. Ltd.
Class III
Target Detachable Coils
Stryker Neurovascular
Class III
Orsiro Mission Sirolimus Eluting Coronary Stent System
BIOTRONIK AG
Class III
Trabecular Metal Reverse Plus Shoulder System
Zimmer Inc.
Class III
MicroCatheter
株式会社カネカ
Class III
Double WireTM and Single Wire Sternum Suture
A&E Medical Corporation
Class III
Xpede Bone Cement
Medtronic Sofamor Danek USA, Inc.
Class III
TOSOH MULTI-CONTROL LEVEL1
Tosoh Corporation
Class III
Pace/Sense Lead
Boston Scientific Corporation
Class III
Implantable Deep Brain Neurostimulation Extension Leads
Medtronic Inc.
Class III
CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences （Ireland）Ltd
Class III
Composite QC level 3
東ソー株式会社
Class III
Maxium Smart C
Gebrüder Martin GmbH & Co. KG
Class III
Aveir Leadless Pacemaker VR
Abbott Medical
Class III
Burr Hole Device
Medtronic Inc.
Class III
HemosIL D-Dimer Controls
Instrumentation Laboratory Company
Class II
Elecsys Vitamin D total III
Roche Diagnostics GmbH
Class II
PlasmaBlade Electrosurgical Device
Medtronic Navigation, Inc.
Class II
Disposable sterile surgical suit
Jiangxi 3L Medical Products Group （Cambodia） Co., Ltd.
Class II
Disposable anesthetic gas absorber
LABORATOIRES FANNAMEX
Class II
PERMA GOLDEN CROWN & KIDS GOLDEN CROWN
（주）신흥
Class II
Single-use endoscopic specimen retrieval bag
（주）세종메디칼
Class II
Rigid Hysteroscopy instruments
DELMONT IMAGING
Class II
Navigated Pak Needle
Boston-Endo Surgical Technologies, Division of Lacey Manufacturing Company, LLC
