In May 2024, 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. 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 May 2024.
| Medical Device/IVD | Manufacturer | Category |
| Patient monitor | 日本光电工业株式会社 | Class III |
| Ethicon Megadyne Electrosurgical Generator | Megadyne Medical Products Inc. | Class III |
| Dry Eye Treatment Instrument | Lumenis Ltd. | Class III |
| bright CT (Oral and maxillofacial cone beam computed tomography equipment) | (주)덴티움아이씨티사업부 | Class III |
| 3D Printed Total Knee System | Smith & Nephew, Inc. | Class III |
| NobelProcera Abutment Titanium | Nobel Biocare AB | Class III |
| Self-etching/self-adhesive resin cement | ITENA CLINICAL | Class III |
| Avenir Complete Hip System | Zimmer Inc. | Class III |
| Agent™ MONORAIL™ Paclitaxel-Coated PTCA Balloon Catheter | Hemoteq AG | Class III |
| DIOnavi-P.MAX | DIO Corporation | Class III |
| iStent inject W Trabecular Micro-Bypass System | Glaukos Corporation | Class III |
| Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | Argon Medical Devices, Inc. | Class III |
| PowerPICC Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet | Bard Access Systems, Inc. | Class III |
| Arthrex FiberTak Suture Anchor | Arthrex, Inc. | Class III |
| Scepter Mini Occlusion Balloon Catheter | MicroVention,Inc. | Class III |
| PFM alloyPFM alloy | The Argen Corporation | Class III |
| Zetuvit Plus/Zetuvit Plus Silicone/Zetuvit Plus Silicone Border | Paul Hartmann AG | Class III |
| BIOLOX delta Universal Taper Ceramic Heads | Howmedica Osteonics Corp. | Class III |
| Acetabular cup system | Waldemar Link GmbH & Co. KG | Class III |
| Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism | Bausch & Lomb Incorporated | Class III |
| ST Internal Implant System | MegaGen Implant Co.,Ltd. | Class III |
| Diapact CRRT Bloodlines | B.Braun Avitum AG | Class III |
| Continuous Single Culture®-NX Complete (CSCM-NXC) | FUJIFILM Irvine Scientific, Inc. | Class III |
| Turnpike Gold Catheter | Vascular Solutions LLC | Class III |
| Dental implant Abutment system | PointNix Co.,Ltd. | Class III |
| Epic Plus Supra Valve | Abbott Medical | Class III |
| Vitrectomy Tip | Bausch&Lomb, Incorporated | Class III |
| SOFIA 88 Catheter | MicroVention, Inc. | Class III |
| Ultrafilter | Gambro Dialysatoren GmbH | Class III |
| Reso-Pac | Hager & Werken GmbH & Co. KG | Class III |
| Epic Plus Valve | Abbott Medical | Class III |
| Biliary Stent System | ALLIUM Ltd. | Class III |
| SDR Plus Bulk Fill Flowable | Dentsply Caulk | Class III |
| TECNIS Eyhance IOL with TECNIS SimplicityTM Delivery System | Johnson & Johnson Surgical Vision, Inc. | Class III |
| Haemodialysis equipment | 東レ・メディカル株式会社 | Class III |
| Imaxeon Pty Ltd | Imaxeon Pty Ltd | Class III |
| Implantable cardioverter defibrillator | Abbott Medical | Class III |
| Ultiri Measurement System | Abbott Medical | Class III |
| Cardiac Resynchronization Therapy Defibrillator | Abbott Medical | Class III |
| Precision Treatment Planning System | Accuray Incorporated | Class III |
| Body Composition Analyzer | BIOPARHOM SAS | Class II |
| Alinity i B·R·A·H·M·S PCT Calibrators | Abbott Ireland Diagnostics Division | Class II |
| Automatic Blood and Body Fluid Analyser | シスメックス株式会社 | Class II |
| XR-Series Automated Hematology Analyzer | SYSMEX CORPORATION | Class II |
| dental anesthesia system | DENTAL HI TEC | Class II |
| DxI 9000 Access Immunoassay Analyzer | Beckman Coulter, Inc. | Class II |
| Auto Ref-Keratometer | POTEC Co., Ltd | Class II |
| MassARRAY Dx System | Agena Bioscience,Inc. | Class II |
| Electrical Drill and Microdebrider Handpieces | Medtronic Xomed, Inc. | Class II |
| S1820 Calibration Solution 1，S1830 Calibration Solution 2 | Radiometer Medical ApS | Class II |
| EnSite™ X EP System Surface Electrode Kit | Abbott Medical Costa Rica Ltda. | Class II |
| Lung function testing | PulmOne Advanced Medical Devices,Ltd. | Class II |
| Low Frequency Therapeutic Apparatus | 株式会社ホーマーイオン研究所 | Class II |
| Revised C-Reactive Protein Calibrator (RCRP CAL) | Siemens Healthcare Diagnostics Inc. | Class II |
| Wireless SpO2 Sensors | Masimo Corporation | Class II |
| Patient Interface Device | LENSAR, Inc | Class II |
| FINESSE REFLEX DSP Forceps | Alcon Laboratories, Inc. | Class II |
| Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set | Cook Incorporated | Class II |
| Patient SafetyNet | Masimo Corporation | Class II |
| Regional Oximeter Sensor | Masimo Corporation | Class II |
| AUTOMATIC ANALYZER | JEOL Ltd. | Class II |
| Alinity i B∙R∙A∙H∙M∙S PCT Controls | Abbott Ireland Diagnostics Division | Class II |
| Chattanooga Intelect F-SW | STORZ MEDICAL AG | Class II |
| Revohem 0.025M Calcium Chloride Solution | SYSMEX CORPORATION | Class II |
| CT Medical Image Processing Software | GE MEDICAL SYSTEMS SCS | Class II |
| CoaguChek INRange | Roche Diagnostics GmbH | Class II |
| CoaguChek XS PT Test PST | Roche Diagnostics GmbH | Class II |
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