China NMPA Newsletter – June 2023


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NMPA New Approvals in June 2023

In June 2023, NMPA approved 264 medical devices, including 46 Class III imported products, 19 Class II imported products, and 198 Class III domestic products.

Below is a list of approved Class III and Class II imported products in June 2023.

Medical Device/IVD Manufacturer Category
Coronary Interventional Surgical Control System Corindus Inc. Class III
CorPath GRX System Accessories Corindus Inc. Class III
Disposable Radio Frequency ( RF ) Needles SPECTRA MEDICAL DEVICES, INC. Class III
IntraSight Mobile System Volcano Corporation Class III
Synchro SELECT Guidewire Stryker Neurovascular Class III
JuggerKnot/JuggerKnotless Soft Anchor Biomet Sports Medicine Class III
OCT Spinal Fixation System Bricon GmbH Class III
TOTAL30 Soft Contact Lenses Alcon Laboratories, Inc. Class III
Supera Peripheral Stent System Abbott Vascular Class III
HEALICOIL Knotless Suture Anchor Smith & Nephew Inc., Endoscopy Division Class III
PowerPort ClearVUE™ ISP Implantable Port Bard Access Systems, Inc. Class III
Total Knee System-Tibial insert and Patella Component b-ONE Ortho, Corp. Class III
Micro Catheter 朝日インテック株式会社 Class III
TherMax Blood Warmer Disposable Baxter Healthcare SA Class III
Ophthalmic Intraoperative OCT system Carl Zeiss Meditec AG Class III
Dual Pulsed Nd:YAG laser Lutronic Corporation Class III
Delivery Catheter CenterPoint Systems LLC Class III
Dental Cone-beam Computed Tomography Dentium Co., Ltd. Class III
Leonardo CeramOptec GmbH Class III
Coagpia Calibrator-N SEKISUI MEDICAL CO.,LTD. Class III
OptiBond eXTRa Universal Kerr Corporation Class III
Rigid scleral contact lens Capricornia Contact Lens Pty Ltd Class III
Trevo NXT ProVue Retriever Stryker Neurovascular Class III
I.V. administration set, Type: UV-Protect B. Braun Melsungen AG Class III
Implantable cardiac pacemakers with cardiac resynchronization therapy Medtronic Inc. Class III
PreXion3D Explorer ブレキシオン株式会社 Class III
Disposable Pressure Transducer Edwards Lifesciences LLC Class III
SpineJet Hydrosurgical handpiece HydroCision, Inc. Class III
ZAP-X Radiosurgery System ZAP Surgical Systems, Inc. Class III
Patient Positioning System C-RAD Positioning AB Class III
Triathlon Partial Knee Resurfacing System Howmedica Osteonics Corp. Class III
Echelon Micro Catheter 朝日インテック株式会社 Class III
GORE TIPS Set Creganna Medical Class III
Global Unite Shoulder System DePuy (Ireland) Class III
Healix Advance BR with Dynacord Medos International SARL Class III
LIAISON® Treponema Screen DiaSorin S.p.A. Class III
LABScreen Single Antigen HLA Class II – Group 1 One Lambda, Inc. Class III
LABScreen Single Antigen HLA Class I – Combi One Lambda, Inc. Class III
Extracorporeal Bloodlines for Blood Purification Fresenius Medical Care AG & Co. KGaA Class III, single-use hydrostatic pressure, adjustable valve hydrocephalus shunt and components system Christoph Miethke GmbH & Co. KG Class III
Form Fit® Hydrogel Canalicular Plug OASIS® Medical, Inc. Class III
R3 HA Coated Acetabular Shells Smith & Nephew, Inc. Class III
Flow Aspiration Catheter ARTHESYS Class III
Truespan Meniscal Repair System Medos International SARL Class III
Penfine Classic pen needle テルモ株式会社 Class III
GEM ChemSTAT CVP 2 Instrumentation Laboratory Company Class II
Knee Joint Instruments Zimmer Inc. Class II
PRG Barrier Coat 株式会社松風 Class II
Micromanipulation Pipettes Vitrolife Sweden AB Class II
Adult Esophageal Balloon Catheter Set CooperSurgical, Inc. Class II
Enzymatic Creatinine_2 Reagents (ECRE_2) 株式会社 ナスカ Class II
CL AIA-PACK CK-MB TEST CUP Tosoh Corporation Class II
SmartLite Pro Modular LED Curing Light DENTSPLY LLC Class II
CareSens II Plus Blood Glucose Monitoring System i-SENS, Inc. Class II
Intelect RPW 2 System DJO FRANCE SAS Class II
GEM ChemSTAT CVP 1 Instrumentation Laboratory Company Class II
WILMO 株式会社エスケーエレクトロニクス Class II
Natural Latex Rubber Condom PLEASURE LATEX PRODUCTS SDN. BHD. Class II
SoftPrep Root Canal Preparation EDTA Cream SPIDENT Co., Ltd. Class II
LIASAUTO Control 2 シスメックス株式会社 Class II
ArtiSential Multi-joint Endoscopic Surgical Instruments LivsMed Inc. Class II
LMA Flexible PreCurved&LAM Flexible PreCurved Cuff Pilot Teleflex Medical Class II
TRAb Calibrators Abbott Ireland Diagnostics Division Class II

China NMPA Approves Innovative Head and Neck X-ray Stereotactic Radiosurgery System for Market

On June 20, 2023, NMPA approved for the registration application of the cutting-edge medical device, the “Head and Neck X-ray Stereotactic Radiosurgery System,” manufactured by ZAP Surgical Systems, Inc. BradyKnows provides the turnkey solution to this innovative device, covering registration, type testing, clinical trial, clinical evaluation, post market surveillance and other aspects of the whole life cycle.

Summary of China Standards of 9706 Series Effective Since May 1, 2023

China standards of 9706 series have been effective since May 1, 2023. The summary is shown as below. It will greatly impact the type testing, registration and modification in China.

NMPA Suspended the Import, Sales and Use of ExFuse Bone Graft of HansBiomed Corp. after Remote QMS Audit

National Medical Products Administration (NMPA) organized a remote QMS inspection of the ExFuse Bone Graft manufactured by HansBiomed Corp. (Certificate # 国械注进20193130564; Address: 64, Yuseong-daero 1628 beon-gil, Yuseong-gu, Daejeon, Korea).

New China CER Website

The new website was built based on the newly updated clinical evaluation requirements and regulation in China under the Order 739.

We are here to help you obtain China market approval for your medical devices with a comprehensive Clinical Evaluation Report (CER). Before jumping to any conclusions, use our newly developed tool for a CER FEASIBILITY SELF-EVALUATION.

Resources – Webinar/Short Videos

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

Resources – New Documents Download

RAPS Convergence 2023

BradyKnows Medical as Sponsor at Booth # 527

MedTech Conference 2023

BradyKnows Medical at Booth # Exhibit Hall A – 547