In May 2024, China NMPA approved 265 medical devices, including 40 Class III imported products, 27 Class II imported products, and 197 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 device. 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 May 2024.
| Medical Device/IVD | Manufacturer | Category |
| Patient Monitor | Nihon Kohden Industry Co., Ltd. | Class III |
| High frequency surgical equipment | Megadyne Medical Products Inc. | Class III |
| Intense pulsed light dry eye therapy device | Lumenis Ltd. | Class III |
| Oral and Maxillofacial Cone Beam Computer Tomography equipment | (주)덴티움아이씨티사업부 | Class III |
| 3D printed knee system | Smith & Nephew, Inc. | Class III |
| Customized titanium alloy abutment | Nobel Biocare AB | Class III |
| Dual-curing resin cement | ITENA CLINICAL | Class III |
| Hip Prosthesis-Femoral Stem | Zimmer Inc. | Class III |
| Paclitaxel coated PTCA balloon catheter | Hemoteq AG | Class III |
| Light-curing temporary crown and bridge resin for additive manufacturing | DIO Corporation | Class III |
| Glaucoma drainage devices | Glaukos Corporation | Class III |
| Vena Cava Filter Retrieval Kit | Argon Medical Devices, Inc. | Class III |
| Peripheral puncture with tracking and positioning Central venous catheter | Bard Access Systems, Inc. | Class III |
| Full suture anchor | Arthrex, Inc. | Class III |
| Occlusion balloon catheter | MicroVention, Inc. | Class III |
| Laser Selective Melting of Cobalt-Chromium Alloy Powder | The Argen Corporation | Class III |
| Sodium polyacrylate fiber dressing | Paul Hartmann AG | Class III |
| Hip joint femoral head | Howmedica Osteonics Corp. | Class III |
| Acetabular Cup System | Waldemar Link GmbH & Co. KG | Class III |
| Soft hydrophilic contact lenses | Bausch & Lomb Incorporated | Class III |
| Dental Implant System | MegaGen Implant Co.,Ltd. | Class III |
| Continuous blood purification circuit | B. Braun Avitum AG | Class III |
| Embryo culture medium | FUJIFILM Irvine Scientific, Inc. | Class III |
| Microcatheter | Vascular Solutions LLC | Class III |
| Dental Implant System Accessories | PointNix Co.,Ltd. | Class III |
| Bioprosthetic valve | Abbott Medical | Class III |
| Disposable vitrectomy tip | Bausch & Lomb, Incorporated | Class III |
| Delivery catheter | MicroVention, Inc. | Class III |
| Ultrafilter | Gambro Dialysatoren GmbH | Class III |
| Periodontal Supplements | Hager & Werken GmbH & Co. KG | Class III |
| Bioprosthetic valve | Abbott Medical | Class III |
| Covered Biliary Stent System | ALLIUM Ltd. | Class III |
| Flowing resin | Dentsply Caulk | Class III |
| Pre-installed intraocular lens | Johnson & Johnson Surgical Vision, Inc. | Class III |
| Hemodialysis equipment | 東レ・メディカル株式会社 | Class III |
| High pressure injection system | Imaxeon Pty Ltd | Class III |
| Implantable cardioverter-defibrillator | Abbott Medical | Class III |
| Fractional Flow Reserve Measurement Device | Abbott Medical | Class III |
| Implantable Cardiac Resynchronization Defibrillator | Abbott Medical | Class III |
| Radiation Therapy Planning Software | Accuray Incorporated | Class III |
| Body Composition Analyzer | BIOPARHOM SAS | Class II |
| Procalcitonin Calibrator | Abbott Ireland Diagnostics Division | Class II |
| Fully automatic blood and body fluid analyzer | シスメックス株式会社 | Class II |
| Fully automatic blood and body fluid analyzer | SYSMEX CORPORATION | Class II |
| Dental anesthesia syringe | DENTAL HI TEC | Class II |
| Fully automatic chemiluminescence immunoassay analyzer | Beckman Coulter, Inc. | Class II |
| Optometry | POTEC Co., Ltd | Class II |
| Time-of-flight mass spectrometry detection system | Agena Bioscience, Inc. | Class II |
| ENT electric handle | Medtronic Xomed, Inc. | Class II |
| Blood gas, electrolyte, metabolite calibration solution | Radiometer Medical ApS | Class II |
| Disposable body surface electrodes | Abbott Medical Costa Rica Ltd | Class II |
| Lung function tester | PulmOne Advanced Medical Devices, Ltd. | Class II |
| Low frequency therapy device | 株式会社ホーマーイオン研究所 | Class II |
| C-reactive protein calibrator | Siemens Healthcare Diagnostics Inc. | Class II |
| Pulse oximeter | Masimo Corporation | Class II |
| Disposable eye fixation patient interface | LENSAR, Inc | Class II |
| Disposable eye forceps | Alcon Laboratories, Inc. | Class II |
| Percutaneous tracheotomy intubation | Cook Incorporated | Class II |
| Central monitoring software | Masimo Corporation | Class II |
| Brain and Regional Blood Oxygen Sensors | Masimo Corporation | Class II |
| Automatic biochemical analyzer | JEOL Ltd. | Class II |
| Procalcitonin quality control | Abbott Ireland Diagnostics Division | Class II |
| Electromagnetic shock wave therapy device | STORZ MEDICAL AG | Class II |
| Calcium chloride solution | SYSMEX CORPORATION | Class II |
| CT image processing software | GE MEDICAL SYSTEMS SCS | Class II |
| Self-testing coagulation tester | Roche Diagnostics GmbH | Class II |
| Prothrombin time test card (electrochemical method) | Roche Diagnostics GmbH | Class II |