In May 2023, NMPA approved 175 medical devices, including 27 Class III imported products, 20 Class II imported products, and 128 Class III domestic products.
NMPA is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. 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 May 2023.
| Medical Device/IVD | Manufacturer | Category |
| Light-curing flowable composite resin | 株式会社松風 | Class III |
| Chameleon PTA balloon catheter | Covidien llc | Class III |
| SlimPort™ M.R.I.™ Ultra Low-Profile Implantable Port | Bard Access Systems, Inc. | Class III |
| NobelProcera Angulated Screw Channel Abutment Zirconia | Nobel Biocare AB | Class III |
| Ultrasound Diagnostic Equipment | キヤノンメディカルシステムズ株式会社 | Class III |
| GORE® VIABAHN® ENDOPROSTHESIS with Heparin Bioactive Surface | W. L. GORE & ASSOCIATES, INC. | Class III |
| DuraGen Plus® Dural Regeneration Matrix | Integra LifeSciences Corporation | Class III |
| Steroid Eluting, Bipolar, Implantable, Screw-in, Ventricular/Atrial, Transvenous Lead | Vitatron Holding B.V. | Class III |
| Aequalis Fracture System | Tornier SAS | Class III |
| Paclitaxel eluting PTA balloon catheter FREEWAY™035 | Eurocor Tech GmbH | Class III |
| Arterial and Venous Cannula | Medtronic, Inc. | Class III |
| TECNIS Eyhance IOL | Johnson & Johnson Surgical Vision, Inc. | Class III |
| Y-Knot All-Suture Anchor | ConMed Corporation | Class III |
| Short Tip Digital IVUS Catheter | Volcano Corporation | Class III |
| iSR’obt Mona lisa | Biobot Surgical Pte Ltd | Class III |
| Novasight Hybrid System | Conavi Medical Inc. | Class III |
| Vitelene XPE Insert | Aesculap AG | Class III |
| Pressure Guide Wire | Volcano Corporation | Class III |
| Implantable Cardioverter/ Defibrillators | MicroPort CRM S.r.l. | Class III |
| Disposable Probes | inomed Medizintechnik GmbH | Class III |
| TANDEM Microspheres | Boston Scientific Corporation | Class III |
| AngioSculpt PTA Scoring Balloon Catheters | Spectranetics Corporation | Class III |
| Oral and maxillofacial cone beam computed tomography equipment | Osstem Implant Co., Ltd. | Class III |
| VENTANA HER2 Dual ISH DNA Probe Cocktail | Roche Diagnostics GmbH | Class III |
| INOmax DSIR Plus Delivery System | Mallinckrodt Manufacturing LLC | Class III |
| OsteoCool RF Ablation Electrode | Medtronic Sofamor Danek USA, Inc. | Class III |
| Disposable Vitrectome | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | Class III |
| Electronic Biliary Endoscope | 富士フイルム株式会社 | Class II |
| MRI Contrast media injector | Ulrich GmbH & Co.KG | Class II |
| LA Control | 积水医疗株式会社 | Class II |
| INTEGRATED DEVICE CORNEAL ANALYZER AND OCULAR BIOMETER | VISIA IMAGING S.r.l. | Class II |
| Proxyt Paste for professional tooth cleaning | Ivoclar Vivadent AG | Class II |
| Introducer Sheath | OSCOR INC. | Class II |
| Auditory analysis platform | PATH MEDICAL GmbH | Class II |
| Infusomat Plus Line | B.Braun Melsungen AG | Class II |
| Sterile Latex Examination Glove | HARTALEGA SDN. BHD. | Class II |
| Disposable Retractor | CooperSurgical, Inc. | Class II |
| Surgical Incision Negative Pressure Drainage Dressing Kit | KCI USA, Inc. | Class II |
| iSR’obt Biopsy Kit | Biobot Surgical Pte Ltd | Class II |
| Total Protein_2 (TP_2) | Siemens Healthcare Diagnostics Inc. | Class II |
| Lumipulse® G Pepsinogen II Calibrators | Fujirebio Inc. | Class II |
| Patient Programmer | Medtronic Inc. | Class II |
| Reusable Patient Return Electrode | Megadyne Medical Products Inc. | Class II |
| aPTT Lupus | Roche Diagnostics GmbH | Class II |
| Continuous Wave 4 Arthroscopy Pump | Arthrex,Inc. | Class II |
| BIOPHEN Heparin LRT | HYPHEN BioMed | Class II |
| GEM ChemSTAT CVP 2 | Instrumentation Laboratory Company | Class II |
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