In July 2022, NMPA approved 197 medical devices, including 20 Class III imported products, 22 Class II imported products, and 152 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 July, 2022.
Medical Device/IVD
Manufacturer
Category
Breast Implant
Mentor
Class III
Vascular Stent Graft
Angiomed GmbH & Co. Medizintechnik KG
Class III
Medical X-ray angiography equipment
GE MEDICAL SYSTEMS SCS
Class III
Hemodynamic and Electrophysiological Recording System
Siemens Healthcare GmbH
Class III
Cochlear implant
Advanced Bionics AG
Class III
Biodentine
SEPTODONT
Class III
Sterile siliconised needles
SEPTODONT
Class III
Ophthalmic Photocoagulator
Lumenis Inc.
Class III
Ear nose X-ray cone beam tomography equipment
Xoran Europe D.o.o
Class III
Catheter sheath system
東郷メディキット株式会社
Class III
Hip Joint Prostheses-Acetabular Liner
Zimmer Inc.
Class III
Hip Joint Prostheses-Acetabular Liner
Zimmer Inc.
Class III
Hydrophilic coated guide catheter
PendraCare International B.V.
Class III
Semiconductor laser hair remover
Formatk Systems Ltd.
Class III
Implantable Pacemaker
Medtronic Inc.
Class III
Syringe kits for drug mixing
MEDEX
Class III
Special needle for disposable implantable drug delivery device
pfm medical cpp SA
Class III
Double curing resin cement
VERICOM CO., LTD.
Class III
Ureteral stents and sets
Urotech GmbH
Class III
Implantable deep brain nerve stimulator
Medtronic Inc.
Class III
Small Bone Powered Surgical Systems
Stryker Instruments
Class II
Disposable electronic bronchoscope
Ambu A/S
Class II
Digital mobile photographic X-ray machine
富士フイルム株式会社
Class II
Shock wave therapeutic apparatus
(주) 한일 티엠
Class II
Creatinine and urea nitrogen electrodes
Nova Biomedical Corporation
Class II
Disposable heated breathing tube
Drägerwerk AG & Co. KGaA
Class II
Body composition analyzer
AKERN SRL
Class II
EEA Circular Stapler with Tri-Staple Technology
Covidien llc
Class II
Disposable Foley Catheters
ConvaTec Limited
Class II
Disposable Trocar
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Class II
Electric peeling machine
Aesculap AG
Class II
Lower limb medical rehabilitation training apparatus
ArjoHuntleigh AB
Class II
Monitoring information management software
Philips Medizin Systeme Böblingen GmbH
Class II
Seawater nasal spray
Jadran-Galenski laboratorij d.d.
Class II
Puncture instrument and accessories for laparoscope
