In March 2023, NMPA approved 290 medical devices, including 33 Class III imported products, 26 Class II imported products, and 227 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 March 2023.
Medical Device/IVD
Manufacturer
Category
Dental Putty-Bioactive Synthetic Bone
Graft
NovaBone Products, LLC
Class III
ONALISA Lidocaine Filler
GENOSS Co., Ltd.
Class III
Accessories for Dental Implants
Biomet 3i, LLC
Class III
Continuous hemodialysis filter and
supporting pipeline
Gambro Industries
Class III
Digital X-ray Radiography and Fluoroscopy
system
Siemens Healthcare GmbH
Class III
Surgical Navigation System
Blue Belt Technologies, Inc.
Class III
Xpert® MTB/RIF Ultra
Cepheid AB
Class III
Lomatuell H Paraffin Gauze Dressing
Lohmann & Rauscher International GmbH & Co. KG
Class III
Single-use body cavity thermal perfusion
line assembly
RanD S.p.A.
Class III
Pipeline™ Flex Embolization Device with
Shield Technology™
Micro Therapeutics, Inc.DBA ev3 Neurovascular
Class III
Umbilical Vessels Catheter
Haolang Medical USA Corporation
Class III
HPV Positive Control Kit
Roche Molecular Systems, Inc.
Class III
Dental implant abutment
SAMWON D.M.P
Class III
Blood Collection Needles
Sarstedt AG & Co. KG
Class III
QUARTZ SPLINT
R.T.D.
Class III
Preloaded Intraocular Lens
HOYA Medical Singapore Pte. Ltd.
Class III
ENROUTE Transcarotid Neuroprotection
System
Silk Road Medical, Inc.
Class III
Avelle Negative Pressure Wound
Therapy(NPWT) System
ConvaTec Limited
Class III
ANATOMIC PEEK PTC Cervical Fusion System
Medtronic Sofamor Danek USA, Inc.
Class III
Image Guided Surgery Platform
Brainlab AG
Class III
ELECTRO DETACH GENERATOR v4
株式会社カネカ
Class III
3Dimensions Mammography System
Hologic, Inc.
Class III
Lumipulse® G HBsAg-Quant Calibrators
Fujirebio Inc.
Class III
Lumipulse® HBsAg Controls
Fujirebio Inc.
Class III
Staining Solution for Cataract Surgery
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Class III
Attune Cementless Knee System
DePuy (Ireland)
Class III
Augmented Mini Baseplate
Biomet Orhopedics
Class III
Surgery navigation system
X-Nav Technologies, LLC
Class III
HydroTac transparent/HydroTac transparent
comfort
Paul Hartmann AG
Class III
Prismaflex HF20 Set
Gambro Industries
Class III
Active Thoracoscopic and Laparoscopic
Hand Instruments
Olympus Winter & Ibe GmbH
Class III
NIM Vital Nerve Monitoring System
Medtronic Xomed, Inc.
Class III
Systane iLux MGD Thermal Pulsation System
Alcon Laboratories, Inc.
Class III
Clip device
ゼオンメディカル株式会社
Class II
Lava™ Esthetic
3M Deutschland GmbH
Class II
Single-use buried needle
(주)서치메디컬
Class II
Passive Thoracoscopic and Laparoscopic
Hand Instruments
