In October 2023, NMPA approved 221 medical devices, including 28 Class III imported products, 16 Class II imported products, and 176 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 October 2023.
Medical Device/IVD
Manufacturer
Category
Pre-milled Abutment Blanks
Institut Straumann AG
Class III
Clareon Toric Aspheric Hydrophobic Acrylic IOL
Alcon Laboratories, Incorporated
Class III
Rist™ Radial Access Selective Catheter
Micro Therapeutics, Inc. DBA ev3 Neurovascular
Class III
Oil for Embryo Culture
FUJIFILM Irvine Scientific, Inc.
Class III
Medizinische Laser
Asclepion Laser Technologies GmbH
Class III
CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences (Ireland） Ltd
Class III
Coblation Halo Wand
ArthroCare Corporation
Class III
CDI H/S Cuvette
Terumo Cardiovascular Systems Corporation
Class III
TECNIS® Symfony Toric Extended Range of Vision IOL
Johnson & Johnson Surgical Vision, Inc.
Class III
Contiplex S 360, continuous peripheral nerve block catheter set with ultrasound-visible stimulation needles
B. Braun Melsungen AG
Class III
MatrixWAVE MMF System
Synthes GmbH
Class III
X-ray equipment for computed tomography
Siemens Healthcare GmbH
Class III
Pruitt® Irrigation Occlusion Catheter
LeMaitre Vascular, Inc.
Class III
TransForm Occlusion Balloon Catheter
Stryker Neurovascular
Class III
V-Loc 90 Absorbable Wound Closure Device
Covidien llc
Class III
PTCA Balloon Catheter
Genoss Co., Ltd.
Class III
Abutments and accessories
APEIRON DENTAL S.r.l
Class III
BD Ultra-Fine™ 2nd Gen Pen Needles
Becton Dickinson and Company
Class III
Affinity NT Oxygenator with Balance Biosurface& Uncoated Cardiotomy/ Venous Reservoir
Medtronic, Inc.
Class III
Persona Personalized Knee System – Persona Ti-Nidium
Zimmer Inc.
Class III
EZStart™ Interference Screw
ConMed Corporation
Class III
Custom Stable™ Rigid Gas Permeable Scleral Contact Lens
Valley Contax Inc.
Class III
Cardiopulmonary bypass in-line blood gas sensor
Terumo Cardiovascular Systems Corporation
Class III
Restoration ADM and MDM Systems
Howmedica Osteonics Corp.
Class III
HANAROSTENT Intestinal Stent
M.I.Tech Co., Ltd.
Class III
White Blood Cell Set
Fresenius Kabi AG
Class III
UltraScore Focused Force PTA Balloon
Bard Peripheral Vascular, Inc.
Class III
OVOIL HEAVY™ for covering of medium during IVF and micro-manipulation procedures
