In April 2024, China NMPA approved 292 medical devices, including 37 Class III imported products, 30 Class II imported products, and 224 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 April 2024.
| Medical Device/IVD | Manufacturer | Category |
| Disposable peripheral plaque ablation device | Volcano AtheroMed Inc. | Class III |
| Intracranial Pressure Sensor Kit | Integra LifeSciences Production Corporation | Class III |
| Factor VIII detection kit (coagulation method) | Roche Diagnostics GmbH | Class III |
| Implantable deep brain neurostimulator | Abbott Medical | Class III |
| Von Willebrand factor detection kit (immunoturbidimetry) | Roche Diagnostics GmbH | Class III |
| Ophthalmic ultrasound biomicroscope | ArcScan, Inc. | Class III |
| Disposable magnetic positioning pressure sensing radiofrequency ablation catheter | Boston Scientific Corporation | Class III |
| Optical interference tomography system | Abbott Medical | Class III |
| Disposable magnetic positioning ring-type mapping catheter | Biosense Webster, Inc. | Class III |
| Intracardiac fiberoptic imaging catheter | CardioFocus, Inc. | Class III |
| Ophthalmic surgical equipment and accessories | Bausch & Lomb Incorporated | Class III |
| Disposable thermal biopsy forceps | オリンパスメディカルシステムズ 株式会社 | Class III |
| Holmium (Ho:YAG) laser therapy device | Lumenis Ltd. | Class III |
| Rib Plate System | Biomet Microfixation | Class III |
| Contact lens lubricant | EUSAN GmbH | Class III |
| Abnormal prothrombin (PIVKA-II) calibrator | Fujirebio Inc. | Class III |
| Blood purification equipment | MEDICA S.p.A | Class III |
| Thoracic and abdominal endoscopic surgery control system | Intuitive Surgical, Inc. | Class III |
| Brain tissue oxygen partial pressure and temperature monitor | Integra LifeSciences (Ireland) Ltd | Class III |
| Adjustable bendable catheter sheath | CardioFocus, Inc. | Class III |
| Mitral valve annuloplasty ring | Medtronic, Inc. | Class III |
| Intraocular lens | Alcon Laboratories, Incorporated | Class III |
| Drug-coated peripheral balloon catheter | Medtronic, Inc. | Class III |
| Pre-installed extended focal depth intraocular lens | Johnson & Johnson Surgical Vision,Inc. | Class III |
| Vitrectomy head | Alcon Laboratories, Inc. | Class III |
| Annuloplasty ring | Corcym S.r.l. | Class III |
| Resin cement for post and core | Bisco, Inc. | Class III |
| Transcatheter aortic valve system | MEDTRONIC INC. | Class III |
| Dental implant system | Institut Straumann AG | Class III |
| Branched thoracic aorta endovascular stent system | W.L. Gore & Associates, Inc. | Class III |
| Dental implants | Alpha-Bio Tec Ltd. | Class III |
| Composite resin repair materials | Dentsply DeTrey GmbH | Class III |
| Optical interference tomography system | Abbott Medical | Class III |
| Fluoroscopic X-ray machine | Philips Medical Systems DMC GmbH | Class III |
| Compound hernia repair patch | Sofradim Production | Class III |
| Disposable multipolar renal artery radiofrequency ablation catheter | Medtronic, Inc. | Class III |
| Renal artery radiofrequency ablation device | Medtronic, Inc. | Class III |
| Disposable negative pressure suction lens | Carl Zeiss Meditec AG | Class II |
| Intermittent pneumatic pressure equipment | Covidien llc | Class II |
| Disposable biopsy forceps | オリンパスメディカルシステムズ 株式会社 | Class II |
| Mechanical root canal files | Maillefer Instruments Holding Sàrl | Class II |
| Orthodontic traction hook | Ormco Corporation | Class II |
| Pulmonary function meter | Vyaire Medical GmbH | Class II |
| Cyclosporine Assay Kit (Chemiluminescence microparticle immunoassay) | Abbott Ireland Diagnostics Division | Class II |
| Quality control materials for blood analyzers | Beckman Coulter, Inc | Class II |
| Iron determination kit (colorimetric method) | Siemens Healthcare Diagnostics Inc. | Class II |
| Cardiac Rhythm Management Equipment Program Controller | BIOTRONIK SE & Co.KG | Class II |
| Dental Implant Surgery Planning Software | X-Nav Technologies，LLC | Class II |
| Cochlear implant adjustment equipment | Cochlear Limited | Class II |
| Pen syringe | Phillips-Medisize A/S | Class II |
| Extracorporeal deep brain neurostimulator | Abbott Medical | Class II |
| Cardiac Rhythm Management Equipment Program Controller | St. Jude Medical Cardiac Rhythm Management Division | Class II |
| Dental image processing software | HDX WILL Corp. | Class II |
| Lactate determination kit (lactate oxidase method) | Siemens Healthcare Diagnostics Inc. | Class II |
| Subretinal injection kit | MedOne Surgical, Inc. | Class II |
| Mask | ResMed Pty Ltd | Class II |
| Mask | ResMed Pty Ltd | Class II |
| Disposable Closure Clip | 株式会社河野製作所 | Class II |
| Shoulder surgery traction fixation system Disposable Accessory Kit | Smith & Nephew Inc. | Class II |
| Drill | Medtronic Powered Surgical Solutions | Class II |
| Root canal files | Maillefer Instruments Holding Sàrl | Class II |
| Biliary dilation catheter | ゼオンメディカル株式会社 | Class II |
| Dental drill | KJ MEDITECH CO., LTD. | Class II |
| Disposable parallel guidewire ureteral introducer sheath | Cook Incorporated | Class II |
| Neuron-specific enolase calibrator | Abbott GmbH | Class II |
| Blood glucose test strips (glucose dehydrogenase method) | Roche Diagnostics GmbH | Class II |
| Creatine kinase isoenzymes/Troponin I/ Myoglobin Assay Kit (Fluorescence immunoassay) | Boditech Med Inc. | Class II |