In March 2024, China NMPA approved 325 medical devices, including 29 Class III imported products, 30 Class II imported products, and 265 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. GVM Medical LLC has extensive experience to support the whole life cycle of medical device. Pls feel free to let us know any questions on China entry via info@gvmmedical.com
Below is a list of approved Class III and Class II imported products in March 2024.
| Medical Device/IVD | Manufacturer | Category |
| Hemodialysis Treatment Equipment | Baxter Healthcare SA | Class III |
| Princess VOLUME Lidocaine | CROMA-PHARMA GmbH | Class III |
| Introcan Safety 2 Closed IV Catheter | B. Braun Melsungen AG | Class III |
| Arthrex Fracture Plates and Screws | Arthrex, Inc. | Class III |
| Sonopet iQ Ultrasonic Aspirator System | Stryker Instruments | Class III |
| Diode laser system | Lumenis Ltd. | Class III |
| Sonopet iQ Ultrasonic Aspirator System Accessories | Stryker Instruments | Class III |
| Lumipulse® G PIVKA Ⅱ-N | Fujirebio Inc. | Class III |
| PreciControl EBV EBNA IgG | Roche Diagnostics GmbH | Class III |
| Ophthalmic Photocoagulator | QUANTEL MEDICAL | Class III |
| BOBBY Balloon Guide Catheter | MicroVention, Inc. | Class III |
| Dental Implant System | HOOWON EDI CO.,LTD. | Class III |
| Soft hydrophilic contact lenses | i-codi Co.,Ltd | Class III |
| TRANSPORT VENTILATOR | BIO-MED DEVICES, INC. | Class III |
| Anti-HBe2 Quality Control (aHBe2 QC) | Siemens Healthcare Diagnostics Inc. | Class III |
| High Frequency Surgical Unit | VIOL.Co.,Ltd. | Class III |
| LIAISON® Control HSV-1 IgG | DiaSorin Inc. | Class III |
| Sterile pen needles for single use | Novo Nordisk A/S | Class III |
| Aveir Catheter Product Family | Abbott Medical | Class III |
| AccuFill Bone Substitute Material | ETEX Corporation ETEX | Class III |
| Ion Endoluminal System | Intuitive Surgical, Inc. | Class III |
| Fully Articulating Catheter | Intuitive Surgical, Inc. | Class III |
| Calibra Veneer | Dentsply Caulk | Class III |
| Hydrus Microstent | Ivantis,Inc. | Class III |
| Abutment system | Cowellmedi Co., Ltd. | Class III |
| DEHT substitution line | B.Braun Avitum AG | Class III |
| TightRail Rotating Dilator Sheath | Philips Image Guided Therapy Corporation | Class III |
| Endo Clip™ III Auto Suture™ Clip Applier with Clip Logic™ Technology | Covidien llc | Class III |
| CAMLOG & CONELOG PROGRESSIVE-LINE Implants | ALTATEC GmbH | Class III |
| VITROS Immunodiagnostic Products TSH3 Calibrators | Ortho-Clinical Diagnostics | Class II |
| Automatic Phoropter | LUNEAU TECHNOLOGY OPERATIONS | Class II |
| Inactive Instruments and Accessories for Ion Endoluminal System | Intuitive Surgical, Inc. | Class II |
| Dornier Diode Laser Fibers | Dornier Medtech America,Inc. | Class II |
| Disposable Bipolar Radiofrequency Surgical Electrode Set | Elliquence, LLC. | Class II |
| VITROS Immunodiagnostic Products TSH3 Reagent Pack | Ortho-Clinical Diagnostics | Class II |
| TEE probes washer/disinfectors | Soluscope SAS | Class II |
| VerifyNow Assay WQC | Accriva Diagnostics, Inc. | Class II |
| Cancer antigen CA125 test kit （CL AIA-PACK CA125 TEST CUP） | Tosoh Corporation | Class II |
| optical coherence tomography (OCT) | APOLLO MEDICAL OPTICS,LTD. | Class II |
| Vibration Balance Training System | LPG Systems | Class II |
| Zirconia Porcelain Block | ストローマン・ジャパン株式会社 | Class II |
| Mask | ResMed Pty Ltd | Class II |
| Cerebral Somatic Tissue Oximeter | Covidien llc | Class II |
| Elecsys FT4 IV | Roche Diagnostics GmbH | Class II |
| Peripheral Vision Probe | Intuitive Surgical, Inc. | Class II |
| Catheter Guide | Intuitive Surgical， Inc. | Class II |
| VITEK MS PRIME | BIOMERIEUX S.A. | Class II |
| Steam Sterilizers | STEELCO SPA | Class II |
| Handheld Optometers | 株式会社ライト製作所 | Class II |
| Enzymatic Creatinine_3 (ECre3) | Siemens Healthcare Diagnostics Inc. | Class II |
| Disposable Endoscope Protective Barrier | COGENTIX MEDICAL, INC. | Class II |
| Natural rubber latex condom | Okamoto Rubber Products Co.,Ltd. | Class II |
| Disposable mesh basket for stone extraction | オリンパスメディカルシステムズ株式会社 | Class II |
| Rotating Surgical Punch | A&E Medical Corporation | Class II |
| DAMON ULTIMA ARCHWIRES | Ormco Corporation | Class II |
| Balloon catheter for lithotripsy | ゼオンメディカル株式会社 | Class II |
| Ennovate Instrument | Aesculap AG | Class II |
| Silicone Gel | Advanced Bio-Technologies, Inc. | Class II |
| Steam Sterilizer | MAQUET GmbH | Class II |