In February 2023, NMPA approved 162 medical devices, including 19 Class III imported products, 22 Class II imported products, and 120 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 February 2023.
Medical Device/IVD
Manufacturer
Category
OR3O Dual Mobility System
Smith & Nephew, Inc.
Class III
AOSept Plus with HydraGlyde lens case
solution
Alcon Laboratories, Inc.
Class III
V-Loc 180 Absorbable Wound Closure Device
Covidien llc
Class III
HOYA iSert Preloaded Intraocular Lens
HOYA Medical Singapore Pte. Ltd.
Class III
Aspiration catheter
Genoss Co., Ltd.
Class III
Dextile™ Anatomical Mesh
Sofradim Production
Class III
Railway Sheathless Access System
Cordis Corporation
Class III
Endoscopic Linear Cutter Reload Kits with
Gripping Surface Technology
