NMPA New Approvals In March 2023
In March 2023, NMPA approved 290 medical devices, including 33 Class III imported products, 26 Class II imported products, and 227 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 March 2023.
| Medical Device/IVD | Manufacturer | Category |
| Dental Putty-Bioactive Synthetic Bone Graft | NovaBone Products, LLC | Class III |
| ONALISA Lidocaine Filler | GENOSS Co., Ltd. | Class III |
| Accessories for Dental Implants | Biomet 3i, LLC | Class III |
| Continuous hemodialysis filter and supporting pipeline | Gambro Industries | Class III |
| Digital X-ray Radiography and Fluoroscopy system | Siemens Healthcare GmbH | Class III |
| Surgical Navigation System | Blue Belt Technologies, Inc. | Class III |
| Xpert® MTB/RIF Ultra | Cepheid AB | Class III |
| Lomatuell H Paraffin Gauze Dressing | Lohmann & Rauscher International GmbH & Co. KG | Class III |
| Single-use body cavity thermal perfusion line assembly | RanD S.p.A. | Class III |
| Pipeline™ Flex Embolization Device with Shield Technology™ | Micro Therapeutics, Inc.DBA ev3 Neurovascular | Class III |
| Umbilical Vessels Catheter | Haolang Medical USA Corporation | Class III |
| HPV Positive Control Kit | Roche Molecular Systems, Inc. | Class III |
| Dental implant abutment | SAMWON D.M.P | Class III |
| Blood Collection Needles | Sarstedt AG & Co. KG | Class III |
| QUARTZ SPLINT | R.T.D. | Class III |
| Preloaded Intraocular Lens | HOYA Medical Singapore Pte. Ltd. | Class III |
| ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | Class III |
| Avelle Negative Pressure Wound Therapy(NPWT) System | ConvaTec Limited | Class III |
| ANATOMIC PEEK PTC Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | Class III |
| Image Guided Surgery Platform | Brainlab AG | Class III |
| ELECTRO DETACH GENERATOR v4 | 株式会社カネカ | Class III |
| 3Dimensions Mammography System | Hologic, Inc. | Class III |
| Lumipulse® G HBsAg-Quant Calibrators | Fujirebio Inc. | Class III |
| Lumipulse® HBsAg Controls | Fujirebio Inc. | Class III |
| Staining Solution for Cataract Surgery | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | Class III |
| Attune Cementless Knee System | DePuy (Ireland) | Class III |
| Augmented Mini Baseplate | Biomet Orhopedics | Class III |
| Surgery navigation system | X-Nav Technologies, LLC | Class III |
| HydroTac transparent/HydroTac transparent comfort | Paul Hartmann AG | Class III |
| Prismaflex HF20 Set | Gambro Industries | Class III |
| Active Thoracoscopic and Laparoscopic Hand Instruments | Olympus Winter & Ibe GmbH | Class III |
| NIM Vital Nerve Monitoring System | Medtronic Xomed, Inc. | Class III |
| Systane iLux MGD Thermal Pulsation System | Alcon Laboratories, Inc. | Class III |
| Clip device | ゼオンメディカル株式会社 | Class II |
| Lava™ Esthetic | 3M Deutschland GmbH | Class II |
| Single-use buried needle | (주)서치메디컬 | Class II |
| Passive Thoracoscopic and Laparoscopic Hand Instruments | Olympus Winter & Ibe GmbH | Class II |
| Infinity Ⅱ LC Clinical Edition / K6460 | Agilent Technologies Singapore (International) Pte. Ltd. | Class II |
| Dental X-ray System | VATECH Co., Ltd. | Class II |
| BIOPHEN UFH Control Plasma | HYPHEN BioMed | Class II |
| Cystoscopes and accessories | SCHÖLLY FIBEROPTIC GMBH | Class II |
| Clarity Ultra Self-Ligating Brackets | 3M Company | Class II |
| Portable Ultrasound Diagnostic Instrument | 日本シグマックス株式会社 | Class II |
| Pancreatic Amylase_2 (PAMY_2) | Siemens Healthcare Diagnostics Inc. | Class II |
| Thyroglobulin (Tg) | Siemens Healthcare Diagnostics Products Limited | Class II |
| Respiratory therapy device | Breas Medical AB | Class II |
| Ambu Neuroline Surface Electrode | Ambu A/S | Class II |
| Laparoscopic passive instruments | GIMMI GmbH | Class II |
| LASEREDGE PLUS | Surgistar Inc. | Class II |
| FLUIMARE | Zambon S.p.A. | Class II |
| Ultrasound Diagnostic Equipment | SAMSUNG MEDISON CO., LTD. | Class II |
| Triglycerides_2 (Trig_2) | Siemens Healthcare Diagnostics Inc. | Class II |
| HITACHI ISE CALIBRATOR (LIQUID) | Hitachi High-Tech Corporation | Class II |
| Dental Ceramic Block | DMAX Co.,Ltd. | Class II |
| Stellant Flex CT Injection System | Bayer Medical Care Inc. | Class II |
| Residual leukocyte counter | NanoEntek, Inc. | Class II |
| Three-dimensional electronic thoracoabdominal endoscope | オリンパスメディカルシステムズ株式会社 | Class II |
| A system and accessories for the measurement of implant stability equipment | Integration Diagnostics Sweden AB | Class II |
| Respiratory therapy device | Breas Medical AB | Class II |
