In August 2022, NMPA approved 210 medical devices, including 25 Class III imported products, 22 Class II imported products, and 161 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 August, 2022.
Medical Device/IVD
Manufacturer
Category
SURGICEL Powder and SURGICEL Endoscopic Applicator
Ethicon,LLC
Class III
Radiofrequency Cannulas
Avanos Medical, Inc.
Class III
HIV Ag/Ab Combo (CHIV) Quality Control
Siemens Healthcare Diagnostics Inc.
Class III
Electroporation Generator
ANGIODYNAMICS, INC.
Class III
Implantable Cardioverter / Defibrillators
BIOTRONIK SE & Co.KG
Class III
SOFT CONTACT LENS
Bausch & Lomb Incorporated
Class III
Freka FKJ Set
Fresenius Kabi AG
Class III
Guidewires
朝日インテック株式会社
Class III
Free prostate specific antigen test kit (chemiluminescence method)
Siemens Healthcare Diagnostics Products Limited
Class III
Implantable Pacemaker
Vitatron Holding B.V.
Class III
Non-Invasive Lipolysis system
Cynosure, LLC
Class III
FilmArray® Meningitis/Encephalitis (ME) Panel
BioFire Diagnostics, LLC
Class III
Single-use sterile needle
(주)동방메디컬 분당지점
Class III
Vertebral Body Replacement
Medtronic Sofamor Danek USA, Inc.
Class III
Orthodontic Fixation Screw
GNI co.,ltd
Class III
MicroCatheter
Stryker Neurovascular
Class III
Surgical Navigation System
Paritic Inc.
Class III
MRIdian Linac System
ViewRay Incorporated
Class III
Infusion Pump
B. Braun Melsungen AG
Class III
Peripheral Implantation of Central Venous Catheter Kit and Accessories
L&Z US, Inc.
Class III
Dental Implants
SIC invent AG
Class III
Percutaneous endoscopic gastrostomy device
Fresenius Kabi AG
Class III
MicroCatheter
ACCURATE MEDICAL THERAPEUTICS LTD
Class III
Solitaire FR Revascularization Device
Micro Therapeutics, Inc.DBA ev3 Neurovascular
Class III
Dental implant system
medentis medical GmbH
Class III
Beating Heart Stabilizing & Positioning Devices
Terumo Cardiovascular Systems Corporation
Class II
CONTOUR Curved Cutter Stapler and Reloads
Ethicon Endo-Surgery, LLC
Class II
Ophthalmic Knives
マニー株式会社
Class II
Oral Dispenser
B.Braun Melsungen AG
Class II
D-Dimer detection kit (immunoturbidimetry)
SYSMEX CORPORATION
Class II
Pepsinogen I (PGI) Test Kit (Chemiluminescence Method)
Fujirebio Inc.
Class II
Calcitonin Test Kit (Microparticle Chemiluminescence Immunoassay)
Siemens Healthcare Diagnostics Inc.
Class II
Platelet Incubator
Helmer Scientific.
Class II
Surgical Table
STERIS SAS
Class II
CONTOUR Plus Blood Glucose Test Strips
Ascensia Diabetes Care Holdings AG
Class II
Medical endoscope LED Light Source
Aesculap AG
Class II
Accessories for Cochlear Implant Systems
Advanced Bionics AG
Class II
Disposable puncture and fascia suture sleeve group
