NMPA New Approvals in January2024

In January 2024, NMPA approved 321 medical devices, including 41 Class III imported products, 33 Class II imported products, and 247 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. BradyKnows elite team has extensive experiences to support the whole life cycle of medical device. 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 January 2024.

Medical Device/IVD	Manufacturer	Category
Cross-linked sodium hyaluronate gel for injection	NEW MEDIC CO., LTD.	Class III
Disposable needle for endoscopy	オリンパスメディカルシステムズ株式会社	Class III
OCT Spinal Fixation System	Medos International SARL	Class III
FIBERGRAFT BG Morsels Bone Graft Substitute	Prosidyan, Inc.	Class III
SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System	Boston Scientific Corporation	Class III
FastThread BioComposite Interference Screw	Arthrex, Inc.	Class III
LuxaBond Universal	DMG Chemisch-Pharmazeutische Fabrik GmbH	Class III
Disposable High-pressure Syringe and Accessories	Imaxeon Pty Ltd	Class III
Knee System	MicroPort Orthopedics,Inc.	Class III
ROUND ENDOBUTTON fixation device	Smith & Nephew Inc., Endoscopy Division	Class III
Erytra Eflexis	Diagnostic Grifols, S.A.	Class III
ILLUMISITE Platform	Covidien llc	Class III
HISCL PIVKA-II Calibrator	SEKISUI MEDICAL CO.,LTD.	Class III
Implantable Spinal Cord Neurostimulator	Medtronic Inc.	Class III
Neuroendoscopy Active Instruments	Aesculap AG	Class III
SedLine Sedation Monitor	Masimo Corporation	Class III
Implantable Pacemaker Systems with a conditional intended use in a MRI environment	MicroPort CRM S.r.l.	Class III
Thermage FLX System	Solta Medical, Inc.	Class III
Paclitaxel-eluting peripheral balloon dilatation catheter	BIOTRONIK AG	Class III
MaxBraid Suture	Teleflex Medical	Class III
Endoscopic Linear Cutter Reload Kits with Gripping Surface Technology	Ethicon Endo-Surgery, LLC	Class III
Disposable High-pressure Connector Tubing	Imaxeon Pty Ltd	Class III
Bellafill	Suneva Medical, Inc.	Class III
Biowy PICC Catheter S Kit	Biowy Corporation	Class III
AestheFill	REGEN Biotech, Inc.	Class III
CapSure™ Permanent Fixation System	Davol, Inc. Subsidiary of C.R.Bard, Inc.	Class III
OPTRELL™ Mapping Catheter with TRUErefTM Technology	Biosense Webster, Inc.	Class III
Negative Control (Monoclonal)	Ventana Medical Systems, Inc.	Class III
Cochlear Implant	Cochlear Limited	Class III
Implantable Cardiac Pacing Leads and related accessories	MicroPort CRM S.r.l.	Class III
Implantable Pacemaker Systems with a conditional intended use in the MRI environment	MicroPort CRM S.r.l.	Class III
ArthroCare ENT Plasma Wands	ArthroCare Corporation	Class III
Implantable Deep Brain Stimulation Directional Lead	Medtronic Inc.	Class III
CharmCore Cement	（주）일청덴탈약품	Class III
Venous and Arterial Cuvettes	Sorin Group Italia S.r.l.	Class III
CD Horizon Spinal System	Medtronic Sofamor Danek USA, Inc.	Class III
Acetabular screws	Howmedica Osteonics Corp	Class III
ENROUTE Transcarotid Stent System	Silk Road Medical, Inc.	Class III
PEEK Interference Screw	Arthrex, Inc.	Class III
Persona Revision Knee System	Zimmer Inc.	Class III
Composite Plate System	CarboFix Orthopedics Ltd.	Class III
Needleless Transfer Device	Takeda Pharmaceuticals U.S.A., Inc.	Class II
SpO2 Sensor	Covidien llc	Class II
Ceftazidime/Avibactam Susceptibility Test Disc	Oxoid Limited	Class II
Automatic Blood and Body Fluid Analyser	シスメックス株式会社	Class II
Automatic Blood and Body Fluid Analyser	希森美康株式会社	Class II
Automatic Blood and Body Fluid Analyser	シスメックス株式会社	Class II
Electronic blood pressure meter	オムロンヘルスケア株式会社	Class II
Pulse CO-Oximeter	Masimo Corporation	Class II
Automatic Blood and Body Fluid Analyser	希森美康株式会社	Class II
Wearable Thermometer	Masimo Corporation	Class II
Automatic Blood and Body Fluid Analyser	シスメックス株式会社	Class II
Anti‑Streptolysin‑O_3 (ASO_3)	Siemens Healthcare Diagnostics Inc.	Class II
Alinity i STAT Myoglobin Reagent Kit	Abbott Ireland Diagnostics Division	Class II
Fingertip Pulse Oximeter	Masimo Corporation	Class II
Vial Adapter	West Pharma. Services IL, Ltd.	Class II
Return Pad	Solta Medical, Inc.	Class II
N Protein Control LC2	Siemens Healthcare Diagnostics Products GmbH	Class II
Single-use contact adhesive heat packs	エステーマイコール株式会社	Class II
N Protein Control LC1	Siemens Healthcare Diagnostics Products GmbH	Class II
Calibrator β2-Microglobulin	Roche Diagnostics GmbH	Class II
Control Set β2-Microglobulin	Roche Diagnostics GmbH	Class II
Mix2Vialᵀᴹ Transfer Device	West Pharma. Services IL, Ltd.	Class II
Natural Latex Rubber Condom	オカモト株式会社	Class II
Disposable surgical caps	Jiangxi 3L Medical Products Group （Cambodia） Co., Ltd.	Class II
Colon Inflator	九州クリエートメディック株式会社	Class II
Alinity i Anti-TPO Reagent Kit	Abbott Ireland Diagnostics Division	Class II
Cochlear implanted system sound processor	Cochlear Limited	Class II
Bone Conducted Hearing Aids	AUDIA AKUSTIK GMBH	Class II
Sacral Neurostimulator Programmer	Medtronic Inc.	Class II
Disposable Shoulder Surgical Instruments	Biomet Orthopedics	Class II
Patient Programmer	Medtronic Inc.	Class II
Sacral Neurostimulation Percutaneous Extension Cable	Medtronic Inc.	Class II
Acquire Pulmonary Endobronchial Ultrasound Fine Needle Biopsy Device	Boston Scientific Corporation	Class II

Sources: NMPA

NMPA New Approvals In January2024

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