China NMPA Newsletter – September 2023

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NMPA New Approvals in September 2023

In September 2023, NMPA approved 187 medical devices, including 25 Class III imported products, 24 Class II imported products, and 137 Class III domestic products.
Below is a list of approved Class III and Class II imported products in September 2023.

Medical Device/IVD	Manufacturer	Category
Ultrascore Focused Force PTA Balloon	Bard Peripheral Vascular, Inc.	Class III
IntraCorporal Lithotripters systems	E.M.S. Electro Medical Systems S.A.	Class III
Tri-Staple™ 2.0 Reinforced Reload	Covidien llc	Class III
AquaBeam Robotic System	PROCEPT BioRobotics Corporation	Class III
Peripheral Coil System	MicroVention, Inc.	Class III
ENTACT Septal Stapler	ArthroCare Corporation	Class III
JuggerStitch Meniscal Repair Devices	Biomet Sports Medicine	Class III
Saber.035 PTA Dilatation Catheter	Cordis Corporation	Class III
AngioSculpt PTA Scoring Balloon Catheter	Spectranetics Corporation	Class III
NeuroBridge A70 Catheter	Acandis GmbH	Class III
Intraocular Lens	Lenstec (Barbados) Inc.	Class III
SafeSheath II Hemostatic Tear-away Introducer	OSCOR INC.	Class III
RF Treatment System	Cynosure, LLC	Class III
Protein C Chrom	Roche Diagnostics GmbH	Class III
Monarch Bronchoscope	Auris Health, Inc.	Class III
Monarch Platform	Auris Health, Inc.	Class III
Abutment and Accessories	Dentium Co., Ltd.	Class III
Bioceramic root canal sealer	META BIOMED CO., LTD.	Class III
Dental Implant System	MIS Implants Technologies Ltd.	Class III
RF20000 Werewolf Coblation System	ArthroCare Corporation	Class III
Extracorporeal Shockwave Lithotripter	Dornier MedTech GmbH	Class III
DiamondTemp Ablation System	Medtronic, Inc.	Class III
DiamondTemp Ablation Catheter	Medtronic, Inc.	Class III
Implantable Pacing Lead	Medtronic, Inc.	Class III
UltraCor Twirl Breast Tissue Marker	Bard Peripheral Vascular, Inc.	Class III
AXS Infinity LS Plus	Stryker Neurovascular	Class II
Injection Cannula Kit	Möller Medical GmbH	Class II
FV Assay Kit (Coagulation Method)	Roche Diagnostics GmbH	Class II
ChemWell®FUSION also known as Project 4800 ELISA & CLIA Analyzer	Awareness Technology, Inc.	Class II
TRAb Reagent Kit	Abbott Ireland Diagnostics Division	Class II
TRAb Controls	Abbott Ireland Diagnostics Division	Class II
Elecsys Androstenedione	Roche Diagnostics GmbH	Class II
Single-use assisted lithotripter	オリンパスメディカルシステムズ株式会社	Class II
Tourniquet Cuffs	Delfi Medical Innovations Inc.	Class II
NoCoding1 Plus Blood Glucose Monitoring System	i-SENS, Inc.	Class II
CIRRUS HD-OCT	Carl Zeiss Meditec, Inc.	Class II
Eurotrol epoc GAS-ISE Metabolites	Eurotrol B.V.	Class II
TECHNOPATH Multi-CHECK Cardiac	Techno-path Manufacturing Ltd	Class II
Dental Digital Imaging Software	Carestream Dental LLC	Class II
Thyroglobulin Calibrators	Abbott GmbH	Class II
Surgical light	Brandon Medical Company Limited	Class II
Assisted reproduction procedure dish	Genea Biomedx Pty Ltd	Class II
4GEM ChemSTAT CVP 4	Instrumentation Laboratory Company	Class II
CL AIA-PACK Myoglobin TEST CUP	東ソー株式会社	Class II
Thyroglobulin Reagent Kit	Abbott GmbH	Class II
Intraoral Optical Scanning System	3Shape TRIOS A/S	Class II
Battery Powered Bone Tissue Surgery Device	OSTEONIC Co., Ltd.	Class II
Regional Oximeter System	Masimo Corporation	Class II
Thyroglobulin Controls	Abbott GmbH	Class II
Medical Device/IVD	Manufacturer	Category
Ultrascore Focused Force PTA Balloon	Bard Peripheral Vascular, Inc.	Class III
IntraCorporal Lithotripters systems	E.M.S. Electro Medical Systems S.A.	Class III
Tri-Staple™ 2.0 Reinforced Reload	Covidien llc	Class III
AquaBeam Robotic System	PROCEPT BioRobotics Corporation	Class III
Peripheral Coil System	MicroVention, Inc.	Class III
ENTACT Septal Stapler	ArthroCare Corporation	Class III
JuggerStitch Meniscal Repair Devices	Biomet Sports Medicine	Class III
Saber.035 PTA Dilatation Catheter	Cordis Corporation	Class III
AngioSculpt PTA Scoring Balloon Catheter	Spectranetics Corporation	Class III
NeuroBridge A70 Catheter	Acandis GmbH	Class III
Intraocular Lens	Lenstec (Barbados) Inc.	Class III
SafeSheath II Hemostatic Tear-away Introducer	OSCOR INC.	Class III
RF Treatment System	Cynosure, LLC	Class III
Protein C Chrom	Roche Diagnostics GmbH	Class III
Monarch Bronchoscope	Auris Health, Inc.	Class III

NMPA Preparing the Guidelines for Registration Review of Real-World Study Designs and Statistical Analyses for Medical Devices

On September 28, 2023, NMPA issued a notice collecting public comments on the Guidelines for Registration Review of Real-World Study Designs and Statistical Analyses for Medical Devices.

NMPA Suspends Import and Use of Swedish XVIVO Perfusion System Due to Major Findings from Remote Overseas Inspection

Recently, the NMPA has announced the suspension of import, distribution, and use of the Swedish XVIVO Perfusion System, approved for use since August 16, 2023, due to major findings from remote overseas inspection.

Resources – Webinar/Short Videos

Please click here to review the record of BradyKnows webinar and short videos.

Resources – New Documents Download

China NMPA Newsletter – September 2023

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