In April 2022, NMPA approved 212 medical devices, including 35 Class III imported products, 20 Class II imported products, and 154 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 April, 2022.
| Medical Device/IVD | Manufacturer | Category |
| Hydrophilic-coated intravascular angiography catheter | Terumo | Class III |
| Ticron Coated Braided Polyester Nonabsorbable Suture | Covidien llc | Class III |
| Safari²™ Guidewires | Lake Region Medical | Class III |
| Healix Advance SP PEEK Anchor | Medos International SARL | Class III |
| LUCENCE | TEKNIMED S.A.S | Class III |
| Vantage Galan 3T MRT-3020 | Canon | Class III |
| Peripheral Coil System | MicroVention,Inc. | Class III |
| Laparoscopic high-frequency surgical instruments | GIMMI GmbH | Class III |
| Implantable Cardioverter/Defibrillators | MicroPort CRM S.r.l. | Class III |
| Stellant Flex Disposable Kit | Bayer Medical Care Inc. | Class III |
| SCENARIA View | Fuji Film | Class III |
| Dermalax Deep | ACROSS CO., LTD. | Class III |
| Collagen-based dental bone filling material | GENOSS Co., Ltd. | Class III |
| Triathlon Tritanium Knee System | Howmedica Osteonics Corp. | Class III |
| True Form Reshapable Guide Wire | Merit Medical Systems, Inc. | Class III |
| Tubing systems for Continuous Blood purification | Fresenius Medical Care AG & Co. KGaA | Class III |
| GO2 Steerable Guide Wire System | Merit Medical Systems,Inc. | Class III |
| Disposable blunt tip needle | (주)제일테크 | Class III |
| HydroSoft 3D Embolic System | MicroVention, Inc. | Class III |
| INDIGO Aspiration System | Penumbra, Inc. | Class III |
| Fresenius HD-Tubing systems | Fresenius Medical Care AG & Co. KGaA | Class III |
| Tubing Systems for Continuous Blood Purification | Fresenius Medical Care AG & Co. KGaA | Class III |
| Orthophos S 3D | Sirona Dental Systems GmbH | Class III |
| Resectoscope accessories | STEMA Medizintechnik GmbH | Class III |
| Hemodynamic and Electrophysiological Recording System | Siemens Healthcare GmbH | Class III |
| 20223130205 | NeoTract, Inc. | Class III |
| Dental Implant | Nobel Biocare AB | Class III |
| CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | Class III |
| ACUVUE® VITA™ Brand Contact Lenses for ASTIGMATISM | Johnson & Johnson Vision Care,Inc. | Class III |
| Fracture and Correction System | In2Bones USA | Class III |
| ABT12 multi-purpose solution | Bausch & Lomb Incorporated | Class III |
| Resection endoscopes and accessories | GIMMI GmbH | Class III |
| Ultrasound Diagnostic Equipment | SAMSUNG MEDISON CO., LTD. | Class III |
| Aptima HIV-1 Quant Dx Assay | Hologic, Inc. | Class III |
| Lumipulse® G Pepsinogen II | Fujirebio Inc. | Class III |
| Erythropoietin (EPO) Quality Control | Siemens Healthcare Diagnostics Inc. | Class II |
| Lumipulse® ProGRP Controls | Fujirebio Inc. | Class II |
| 3D OCT-1 Maestro2 | Topcon | Class II |
| Ambu aView Monitor | Ambu A/S | Class II |
| Total Bile Acids | SENTINEL CH. S.p.A. | Class II |
| Therapy Monitor | Fresenius Medical Care AG & Co. KGaA | Class II |
| Rifampicin Susceptibility Test Disc | Oxoid Limited | Class II |
| Amoxycillin/Clavulanic Acid Susceptibility Test Disc | Oxoid Limited | Class II |
| Surgical Microscope | Leica Microsystems (Schweiz) AG | Class II |
| Vitamin D total II CalSet | Roche Diagnostics GmbH | Class II |
| CONTOUR CARE blood glucose meter | Ascensia Diabetes Care Holdings AG | Class II |
| EUROArrayScanner | EUROIMMUN Medizinische Labordiagnostika AG | Class II |
| Acrobat® 2 Calibrated Tip Wire Guide | Wilson-Cook Medical, Inc. | Class II |
| Primescan AC | Sirona Dental Systems GmbH | Class II |
| Androstenedione (ANDRO) | Siemens Healthcare Diagnostics Inc. | Class II |
| P-FDP CALIBRATOR | SYSMEX CORPORATION | Class II |
| D-Dimer CALIBRATOR NEO | SYSMEX CORPORATION | Class II |
| LIASAUTO CONTROL | SYSMEX CORPORATION | Class II |
| The F1 Battery Powered Micro system | Stryker Instruments | Class II |
| SpyScope DS II Access and Delivery Catheter | Boston Scientific Corporation | Class II |
Sources: NMPA
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