NMPA New Approvals In February 2023
In February 2023, NMPA approved 162 medical devices, including 19 Class III imported products, 22 Class II imported products, and 120 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 February 2023.
| Medical Device/IVD | Manufacturer | Category |
| OR3O Dual Mobility System | Smith & Nephew, Inc. | Class III |
| AOSept Plus with HydraGlyde lens case solution | Alcon Laboratories, Inc. | Class III |
| V-Loc 180 Absorbable Wound Closure Device | Covidien llc | Class III |
| HOYA iSert Preloaded Intraocular Lens | HOYA Medical Singapore Pte. Ltd. | Class III |
| Aspiration catheter | Genoss Co., Ltd. | Class III |
| Dextile™ Anatomical Mesh | Sofradim Production | Class III |
| Railway Sheathless Access System | Cordis Corporation | Class III |
| Endoscopic Linear Cutter Reload Kits with Gripping Surface Technology | Ethicon Endo-Surgery, LLC | Class III |
| Healix Advance SP BIOCOMPOSITE Anchor | Medos International SARL | Class III |
| Prismaflex ST Set | Gambro Industries | Class III |
| Cardioblate Surgical Ablation System | Medtronic Inc. | Class III |
| Rotor-Gene Q MDx | Analytik Jena AG | Class III |
| CEREBASE DA Guide Sheath | Medos International SARL | Class III |
| FAST-FIX FLEX | Smith & Nephew Inc. Endoscopy Division | Class III |
| Hemodialysis System | Fresenius Medical Care AG & Co.KGaA | Class III |
| OCTARAY Mapping Catheter with TRUEref Technology | Biosense Webster, Inc. | Class III |
| Total Knee System-Tibial baseplate | b-ONE Ortho, Corp. | Class III |
| MOBIO™ Total Knee System-Femoral Condyle | b-ONE Ortho, Corp. | Class III |
| Hybrid Closed Loop Insulin Delivery System | Medtronic MiniMed | Class III |
| CEREC Zirconia+ | DeguDent GmbH | Class II |
| Endoscopic Accessories | AMNOTEC International Medical GmbH | Class II |
| Solo Hydro Hybrid Guidewire | Heraeus Medical Components, LLC | Class II |
| InnovEyes Sightmap | WaveLight GmbH | Class II |
| Vision testing instrument | 株式会社トプコン | Class II |
| MorSafe® Tissue Morcellation Bag | Veol Medical Technologies Pvt. Ltd | Class II |
| Video Upper GI Scope | HOYA株式会社 | Class II |
| Video Bronchoscope | HOYA株式会社 | Class II |
| Video endoscope | 富士フイルム株式会社 | Class II |
| Video endoscope | 富士フイルム株式会社 | Class II |
| Reusable laser fibres | LISA Laser Products GmbH | Class II |
| Video Upper GI Scope | 富士フイルム株式会社 | Class II |
| BIOPHEN UFH Calibrator | HYPHEN BioMed | Class II |
| BIOPHEN LMWH Control Plasma | HYPHEN BioMed | Class II |
| Endoscope Reprocessor | CANTEL MEDICAL (ITALY)SRL | Class II |
| Dosimetry Systems | IBA Dosimetry GmbH | Class II |
| Mammography Images Processing Software | Siemens Healthcare GmbH | Class II |
| Camera Head | HOYA株式会社 | Class II |
| Somnograph | SOMNOmedics GmbH | Class II |
| BIOPHEN Heparin Calibrator | HYPHEN BioMed | Class II |
| VITROS XT 7600 Integrated System | Ortho-Clinical Diagnostics, Inc. | Class II |
| Dental Implant Surgical Drill | HAENAEM Co., Ltd. | Class II |
