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
M.blue(plus), 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
VENOUS RESERVOIR/CARDIOTOMY, OXYGENATOR
UNIT INTEGRATED WITH HEAT EXCHANGER
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.
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.
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).
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.
