In August 2023, NMPA approved 288 medical devices, including 33 Class III imported products, 24 Class II imported products, and 229 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 August 2023.
| Medical Device/IVD | Manufacturer | Category |
| Heart-Lung Support System | Maquet Cardiopulmonary GmbH | Class III |
| Novasight Hybrid Catheter | Conavi Medical Inc. | Class III |
| MynxGrip Vascular Closure Devices | Cardinal Health | Class III |
| Preloaded Intraocular Lens | HOYA Medical Singapore Pte. Ltd. | Class III |
| 3M Tegaderm Silicone Foam Dressing | 3M Company | Class III |
| CPX4 PLUS Smooth Breast Tissue Expanders | Mentor | Class III |
| Aspheric Multifocal Lens | Teleon Surgical B.V | Class III |
| Intraocular lens | Carl Zeiss Meditec AG | Class III |
| TightRope | Arthrex, Inc. | Class III |
| GlidePath™ Long-Term Hemodialysis Catheter | Bard Access Systems, Inc. | Class III |
| High Flux Dialyzer | Bellco S.r.l. | Class III |
| Palindrome Precision H Chronic Catheter | Covidien llc | Class III |
| Blank Cal | Roche Diagnostics GmbH | Class III |
| Ticron Coated Braided Polyester Nonabsorbable Suture | Covidien llc | Class III |
| FIBERGRAFT BG Putty Bone Graft Substitute | Prosidyan, Inc. | Class III |
| LIAISON XL murex HBsAg Quant | DiaSorin Italia S.p.A. | Class III |
| ORTHO Optix Reader | Ortho-Clinical Diagnostics | Class III |
| XVIVO Perfusion System | XVIVO Perfusion AB | Class III |
| IntraSight Integrated System | Volcano Corporation | Class III |
| Surgical Navigation System | Quantum Surgical SAS | Class III |
| Comprehensive Reverse Shoulder System | Zimmer Inc. | Class III |
| CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | Class III |
| Tigertriever Revascularization Device | Rapid Medical Ltd. | Class III |
| Harmonize | Kerr Corporation | Class III |
| i-ED Coil | 株式会社カネカ | Class III |
| HOYA iSert Preloaded Intraocular Lens | HOYA Medical Singapore Pte. Ltd. | Class III |
| Affixus Natural Nail Humeral Nail System | Zimmer GmbH | Class III |
| Implant | Noris Medical Ltd. | Class III |
| Free Protein S | Roche Diagnostics GmbH | Class III |
| Plasma HF-resection electrodes | Olympus Winter & Ibe GmbH | Class III |
| Semi-Automated External Defibrillator | Physio-Control, Inc. | Class III |
| Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | Class III |
| ENSEAL X1 Tissue Sealer | Ethicon Endo – Surgery, LLC | Class III |
| Built-in Scaler | E.M.S. Electro Medical Systems S.A. | Class II |
| Ambulatory Blood Pressure Recorder | SOMNOmedics GmbH | Class II |
| Endoscopes of Laparoscopy | KARL STORZ SE & Co. KG | Class II |
| DD medical zirconia and accessories | Dental Direkt GmbH | Class II |
| X-ray Tube Assemblies of Rotating Anode | Philips Medical Systems DMC GmbH | Class II |
| Intraoral Scanner | MEDIT Corp. | Class II |
| Orthodontic bracket | BIOCETEC Co., Ltd. | Class II |
| ENT MR8 Burs | Medtronic Powered Surgical Solutions | Class II |
| VITA LUMEX AC | VITA Zahnfabrik, H. Rauter GmbH & Co. KG | Class II |
| CalSet Androstenedione | Roche Diagnostics GmbH | Class II |
| cobas GLU QC kit | Roche Diagnostics GmbH | Class II |
| cobas GLU linearity kit | Roche Diagnostics GmbH | Class II |
| 3GEM ChemSTAT CVP 3 | Instrumentation Laboratory Company | Class II |
| TIPCAM1 Rubina | KARL STORZ SE & Co.KG | Class II |
| Electrically operated hospital bed with scales | LINET spol. s r.o. | Class II |
| FX Assay Kit (Coagulation Method) | Roche Diagnostics GmbH | Class II |
| Porcelain Etch Gel | Pulpdent Corporation | Class II |
| Sterile Protective Cover | Jiangxi 3L Medical Products Group (Cambodia) Co., Ltd | Class II |
| FMS VUE II Fluid Management and Tissue Debridement System | Medos International SARL | Class II |
| FVII Assay Kit (Coagulation Method) | Roche Diagnostics GmbH | Class II |
| Image processing unit | オリンパスメディカルシステムズ株式会社 | Class II |
| Cercon ht ML | DeguDent GmbH | Class II |
| Dental Drills | Biomet 3i, LLC | Class II |
| Ultrasonic scaler | SATELEC A Company of ACTEON Group | Class II |
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