In October 2022, NMPA approved 204 medical devices, including 34 Class III imported products, 23 Class II imported products, and 146 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 October, 2022.
Medical Device/IVD
Manufacturer
Category
Light curing composite resin
株式会社ジーシーデンタルプロダクツ
Class III
Palindrome Precision Chronic Catheter
Covidien llc
Class III
EMBOVAC Aspiration Catheter
Medos International SARL
Class III
Octrode Trial Lead Kit
St.Jude Medical
Class III
Ophthalmic Surgical System Qube pro
Fritz Ruck Ophthalmologische Systeme GmbH
Class III
Coagulation controls
Roche Diagnostics GmbH
Class III
Sensation Plus Intra-Aortic Balloon Catheters
Datascope Corp.
Class III
VITROS Immunodiagnostic Products HIV Combo Controls
Ortho-Clinical Diagnostics
Class III
Depth Electrode
PMT Corporation
Class III
Corneal cross-linking system
Iromed Group S.r.l.
Class III
PERFORMER HT
RanD S.p.A.
Class III
VISION EF Sensor-Ureterorenoscope and Accessories
Richard Wolf GmbH
Class III
Ultrasound Diagnostic Equipment
SAMSUNG MEDISON CO., LTD.
Class III
Microwave therapeutics
주식회사 한일티엠
Class III
AMPLATZER Piccolo Occluder
Abbott Medical
Class III
Radiopaque bone cement for Percutaneous Vertebral Augmentation (PVA) procedures
G21 S.r.l.
Class III
Amplatzer TorqVue LP Catheter
Abbott Medical
Class III
Sentinel Cerebral Protection System
Boston Scientific Corporation
Class III
Cross-linked Sodium Hyaluronate Gel for Injection
CG Bio Co., Ltd.
Class III
TECNIS® Toric II 1-Piece IOL
Johnson & Johnson Surgical Vision, Inc.
Class III
Surpass Evolve Flow Diverter System
Stryker Neurovascular
Class III
Theraputic plasma exchange tubing
Fresenius Medical Care AG & Co. KGaA
Class III
Perclose ProStyle Suture-Mediated Closure and Repair System
Abbott Vascular
Class III
Contact lens lubricants
SANTEN
Class III
Selective and Hyperselective Catheters
BALT EXTRUSION SAS
Class III
EsBond Light Cured Bonding Agent
SPIDENT Co., Ltd.
Class III
Silicone Hydrogel Daily Color Contact Lens
Visco Technology Sdn. Bhd.
Class III
LASSOSTAR Circular Mapping Catheter
Biosense Webster, Inc.
Class III
HemosIL Calibration Plasma
Instrumentation Laboratory Company
Class III
WATCHMAN™ TruSealt™ Access System
Boston Scientific Corporation
Class III
Trident X3 EtO Acetabular Inserts
Howmedica Osteonics Corp.
Class III
Double-deck artificial dermal repair materials
グンゼ株式会社
Class III
Freka Intestinal Tube
Fresenius Kabi AG
Class III
Pump Heads
Medos Medizintechnik AG
Class III
X-ray flat panel detector
キヤノン電子管デバイス株式会社
Class II
Stat Profile Prime Plus MicroSensor Card
Nova Biomedical Corporation
Class II
Endoscopic Camera System
GIMMI GmbH
Class II
Perfusion pump
Biosense Webster(Israel)Ltd.
Class II
EV3.0 Camera Head & Sterile Cover
Aesculap AG
Class II
Intense Pulsed Non-Coherent Light
CyDen Ltd
Class II
Multichannel Electrocardiograph
Vyaire Medical GmbH
Class II
Highspeed Surgical Drill System
adeor Medical AG
Class II
Vital Signs Monitor
Welch Allyn, Inc.
Class II
Mentor Resterilizable Gel Breast Implant Sizer
Mentor
Class II
Aqua Maris®Baby nasal spray/Aqua Maris®Clean nasal spray
Jadran-Galenski laboratorij d.d.
Class II
LATEX SURGICAL GlOVE
Careglove Global Sdn. Bhd.
Class II
Dental implant drills
ORNAGHI LUIGI & C.S.n.c.
Class II
Shine Liquid
Genoss Co., Ltd.
Class II
IDS-iSYS 25 VitDS
Immunodiagnostic Systems Limited
Class II
Beam scanning measurement system – dose measurement array
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
