In July 2023, NMPA approved 197 medical devices, including 21 Class III imported products, 21 Class II imported products, and 150 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 July 2023.
Medical Device/IVD
Manufacturer
Category
Dental Implant
Dentis Co.,Ltd.
Class III
Dual Mobility Vivacit-E Polyethylene Hip Bearing
Zimmer Inc.
Class III
Clearlab eyedia multi-purpose solution
Clearlab SG Pte. Ltd.
Class III
NovaSure Impedance Controlled Endometrial Ablation System
Hologic, Inc.
Class III
Endoskeleton TCS Interbody System
Medtronic Sofamor Danek USA, Inc.
Class III
Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
Medtronic Sofamor Danek USA, Inc.
Class III
Persona Trabecular Metal Knee System
Zimmer Inc.
Class III
SP-CL Hip Stem Prosthesis
Waldemar Link GmbH & Co.KG
Class III
CP-Monitor
Spiegelberg(GmbH&Co)KG
Class III
Opalescence Endo Endodontic Whitening System
Ultradent Products, Inc.
Class III
ROSA Recon Platform
Zimmer CAS
Class III
Comprehensive Reverse Shoulder System
Zimmer Inc.
Class III
Medical System for Ultrasound Diagnosis
Compumedics Germany GmbH
Class III
NeuroSpeed PTA Balloon Catheter
Acandis GmbH
Class III
AcrySof™ IQ Vivity™ Toric Extended Vision IOL
Alcon Laboratories, Incorporated
Class III
Self-curing general purpose adhesive for dental gum adhesives
株式会社トクヤマデンタル
Class III
Holmium (Ho:YAG) laser therapy machine
Lumenis Limited
Class III
Ozone Generators
Dr.J.Hansler GmbH
Class III
Infusion Syringe Pump
B. Braun Melsungen AG
Class III
Diacan Flex
B.Braun Avitum AG
Class III
Preloaded System Intraocular Lens
HOYA Medical Singapore Pte. Ltd.
Class III
Surgical Saw Blade
Zimmer Surgical, Inc.
Class II
DAMON Q2 SINGLE PATIENT KIT
Ormco Corporation
Class II
Sterile Nitrile Examination Glove
Hartalega Sdn. Bhd.
Class II
Metal Self-ligating bracket
American Orthodontics
Class II
MicroScan Pos Combo Panel Type 44
Beckman Coulter, Inc.
Class II
Tina-quant Soluble Transferrin Receptor II（STFR2）
Roche Diagnostics GmbH
Class II
HISCL KL-6 Assay Kit
SEKISUI MEDICAL CO., LTD.
Class II
Line Polarized Light Pain Therapy
東京医研株式会社
Class II
Mick Applicator System
Mick Radio-Nuclear Instruments，Inc.
Class II
Sof-Tray Sheets
Ultradent Products, Inc.
Class II
Midas Rex MR8 ClearView Tools
Medtronic Powered Surgical Solutions
Class II
Guide drills for dental implant system
PointNix Co.,Ltd.
Class II
ElisaRSR™ IA-2 Ab Version 2
RSR Limited
Class II
Ultra-clean bench for in vitro fertilization
ASTEC CO.,LTD.
Class II
Electronic Biliary Endoscopy
オリンパスメディカルシステムズ株式会社
Class II
ENT MR8 ClearView
Medtronic Powered Surgical Solutions
Class II
PHOTO THERMOLYSIS DEVICE
Active Optical Systems Ltd.
Class II
Low Frequency Combination Stimulator
TRYCAM TECHNOLOGY CO.,LTD.
Class II
Factor II Assay Kit (Coagulation Method)
Roche Diagnostics GmbH
Class II
Single-use Lens Injection System
ODC Industries
Class II
POLYAMID monofilament non absorbable sterile surgical suture
