In September 2022, NMPA approved 222 medical devices, including 24 Class III imported products, 33 Class II imported products, and 163 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 September, 2022.
Medical Device/IVD
Manufacturer
Category
Captivator Cold Single-Use Polypectomy Snare
Boston Scientific Corporation
Class III
Air Optix Plus Hydraglyde For Astigmatism Soft Contact Lens
Alcon Laboratories, Inc.
Class III
Cranial Fixation Sterile Set
Rebstock Instruments GmbH
Class III
Diagnostic Ultrasound System
Siemens Medical Solutions
USA, Inc.
Class III
Radiation Treatment Planning System
Elekta Solutions AB
Class III
Patient Monitor
Philips Medizin Systeme
Böblingen GmbH
Class III
OMNIset TPE
B.Braun Avitum AG
Class III
Dental Implant
Nobel Biocare AB
Class III
SURGICEL FIBRILLAR Absorbable Hemostat
Ethicon, LLC
Class III
Guidewires
日本ライフライン株式会社
Class III
Legion System and Accessories
Alcon Laboratories, Inc.
Class III
ArthroCare ENT Plasma Wands
ArthroCare Corporation
Class III
LIAISON® XL murex HCV Ab
DiaSorin S.p.A.
Class III
Idylla™ System
Biocartis NV
Class III
Lasersystem for assisted reproduction
Vitrolife GmbH
Class III
Ennovate Spinal System Implants
Aesculap AG
Class III
Titanium Suture Anchor
Arthrex,Inc.
Class III
AQUACEL® Foam Pro Dressing
ConvaTec Limited
Class III
Soft hydrophilic contact lens
株式会社メニコン
Class III
HD-Tubing systems Accessories
Fresenius Medical Care AG
& Co. KGaA
Class III
Computed tomography x-ray system
GE MEDICAL SYSTEMS,LLC
Class III
VNS Therapy System
LivaNova USA, Inc.
Class III
Surgical Microscope
Carl Zeiss Meditec AG
Class III
BIOSURE REGENESORB Interference Screw
Smith & Nephew Inc.,
Endoscopy Division
Class III
Tracheostomy Tube
Covidien llc
Class II
Lens Fragmentation Device
Carl Zeiss Meditec AG
Class II
GARDIAN TM 25 mm SYRINGE FILTERS
Pall Medical, a Division of
Pall International Sàrl
Class II
Dental Ceramics
Institut Straumann AG
Class II
Stat Profile Prime Plus Auto QC Cartridge
Nova Biomedical Corporation
Class II
VITEK 2 AST-YS08
BIOMERIEUX S.A.
Class II
Stimulator for Functional Electrical Stimulation
HASOMED GmbH
Class II
Body Composition Analyzer
InBody Co., Ltd.
Class II
Insufflator
Aesculap AG
Class II
Hawkins Breast Localization Needle
Argon Medical Devices, Inc.
Class II
Minivette® POCT
SARSTEDT AG & Co. KG
Class II
Hawkins Breast Localization Needle
Argon Medical Devices, Inc.
Class II
Angel of Water Colon Hydrotherapy System
Lifestream purification
Systems, LLC
Class II
qUAntify Plus Control
Bio-Rad Laboratories, Inc.
Class II
Erythropoietin (EPO)
Siemens Healthcare
Diagnostics Inc.
Class II
Medical Image Processing Software
Vital Images, Inc.
Class II
Looking Glass 4K Integrated Visualization System
ConMed Corporation
Class II
EV3.0 Camera Control Unit
Aesculap AG
Class II
EEG recorder
lifelines Ltd.
Class II
Medical cooling therapeutics
日本シグマックス株式会社
Class II
Stat Profile Prime Plus Calibrator Cartridge
Nova Biomedical Corporation
Class II
CalSet Vitamin D total III
Roche Diagnostics GmbH
Class II
PreciControl Vitamin D total II
Roche Diagnostics GmbH
Class II
Videocolposcope
Karl Kaps GmbH & Co. KG
Class II
Fundus Camera
Natus Medical Incorporated
DBA Excel-Tech Ltd.(XLTEK)
Class II
Autorefractometer
株式会社ニデック
Class II
GIA stapler and cartridge with Tri-Staple technology
