In June 2024, NMPA approved 134 medical devices, including 14 Class III imported products, 11 Class II imported products, and 109 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 June 2024.
Medical Device/IVD
Manufacturer
Category
OptiCross 35 15 MHz Peripheral Imaging Catheter
Boston Scientific Corporation
Class III
Cochlear Implant
MED-EL Elektromedizinische Geräte GmbH
Class III
Afterloader System
Varian Medical Systems, Inc.
Class III
SPECT/CT
GE Medical Systems Israel, Functional Imaging
Class III
HeartLight®X3 Catheter
CardioFocus, Inc.
Class III
ENT Treatment Guidance System
Medtronic Navigation, Inc.
Class III
Urgoclean Ag Pad
LABORATOIRES URGO
Class III
RAPID RHINO Epistaxis Device
ArthroCare Corporation
Class III
Arterial Catheter
Haolang Medical USA Corporation
Class III
FIBERGRAFT BG Putty Bone Graft Substitute
Prosidyan, Inc.
Class III
Sling for female urinary incontinence
Promedon S.A.
Class III
STANDARDTM Q HIV 1/2 Ab 3-Line Test
SD Biosensor, Inc.
Class III
CranioMaxillofacial System
General Implants GmbH Deutschland
Class III
Dental Implant
Neobiotech Co.,Ltd.
Class III
Fundus Viewing System
Carl Zeiss Meditec AG
Class II
HemoCue Hb 801 Analyzer
HemoCue AB
Class II
Acoustic Respiration Sensor
Masimo Corporation
Class II
Kangaroo OMNI Enteral Feeding Sets
Cardinal Health 200, LLC
Class II
Orthopedics Surgical Instruments
Arthrex, Inc.
Class II
Sterile Single Use Corneal Trephines & Sterile Single Use Donor Trephine Punches
