NMPA New Approvals In March 2023


2023-04-24

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

Sources: NMPA