In June 2024, China NMPA approved 134 medical devices, including 14 Class III imported products, 11 Class II imported products, and 109 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. GVM Medical LLC has extensive experience to support the whole life cycle of medical devices. Pls feel free to let us know any questions on China entry via info@gvmmedical.com
Below is a list of approved Class III and Class II imported products in June 2024.
| Medical Devices/IVD | Manufacturer | Category |
| Single-use peripheral intravascular ultrasound diagnostic catheter | Boston Scientific Corporation | Class III |
| Cochlear Implant | MED-EL Elektromedizinische Geräte GmbH | Class III |
| Afterloading machine | Varian Medical Systems, Inc. | Class III |
| Single Photon Emission X-ray Computed Tomography Imaging System | GE Medical Systems Israel, Functional Imaging | Class III |
| Disposable balloon laser ablation catheter | CardioFocus, Inc. | Class III |
| ENT surgery navigation equipment | Medtronic Navigation, Inc. | Class III |
| Silver sulfate-containing hydrophilic fiber dressing | LABORATOIRES URGO | Class III |
| Nasal balloon | ArthroCare Corporation | Class III |
| Disposable Arterial Catheter Set | Haolang Medical USA Corporation | Class III |
| Bioglass bone filler | Prosidyan, Inc. | Class III |
| Urethral sling | Promedon SA | Class III |
| Human immunodeficiency virus (HIV1+2) antibody detection kit (colloidal gold method) | SD Biosensor, Inc. | Class III |
| Metal Craniomaxillofacial Plate System | General Implants GmbH Deutschland | Class III |
| Dental Implants | Neobiotech Co.,Ltd. | Class III |
| Fundus imaging device | Carl Zeiss Meditec AG | Class II |
| Hemoglobin Analyzer | HemoCue AB | Class II |
| Respiratory rate sensor | Masimo Corporation | Class II |
| Disposable enteral nutrition pump tube | Cardinal Health 200, LLC | Class II |
| Orthopedic surgical instruments | Arthrex, Inc. | Class II |
| Single-use donor and recipient corneal trephine | Network Medical Products Ltd. | Class II |
| Dyeing Porcelain Powder | Matsukaze Co., Ltd. | Class II |
| Dental diaphragm | Bay Materials LLC | Class II |
| Needle for bronchial navigation operation control system | Intuitive Surgical, Inc. | Class II |
| Disposable sterile rubber surgical gloves | Ansell Lanka(Pvt) Limited | Class II |
| Disposable sterile surgical gloves | Hartalega NGC Sdn. Bhd. | Class II |