Homepage > Nachrichten > Text

NMPA New Approvals In May 2023

2023-06-27

In May 2023, NMPA approved 175 medical devices, including 27 Class III imported products, 20 Class II imported products, and 128 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 May 2023.

Medical Device/IVD Manufacturer Category
Light-curing flowable composite resin 株式会社松風 Class III
Chameleon PTA balloon catheter Covidien llc Class III
SlimPort™ M.R.I.™ Ultra Low-Profile Implantable Port Bard Access Systems, Inc. Class III
NobelProcera Angulated Screw Channel Abutment Zirconia Nobel Biocare AB Class III
Ultrasound Diagnostic Equipment キヤノンメディカルシステムズ株式会社 Class III
GORE® VIABAHN® ENDOPROSTHESIS with Heparin Bioactive Surface W. L. GORE & ASSOCIATES, INC. Class III
DuraGen Plus® Dural Regeneration Matrix Integra LifeSciences Corporation Class III
Steroid Eluting, Bipolar, Implantable, Screw-in, Ventricular/Atrial, Transvenous Lead Vitatron Holding B.V. Class III
Aequalis Fracture System Tornier SAS Class III
Paclitaxel eluting PTA balloon catheter FREEWAY™035 Eurocor Tech GmbH Class III
Arterial and Venous Cannula Medtronic, Inc. Class III
TECNIS Eyhance IOL Johnson & Johnson Surgical Vision, Inc. Class III
Y-Knot All-Suture Anchor ConMed Corporation Class III
Short Tip Digital IVUS Catheter Volcano Corporation Class III
iSR’obt Mona lisa Biobot Surgical Pte Ltd Class III
Novasight Hybrid System Conavi Medical Inc. Class III
Vitelene XPE Insert Aesculap AG Class III
Pressure Guide Wire Volcano Corporation Class III
Implantable Cardioverter/ Defibrillators MicroPort CRM S.r.l. Class III
Disposable Probes inomed Medizintechnik GmbH Class III
TANDEM Microspheres Boston Scientific Corporation Class III
AngioSculpt PTA Scoring Balloon Catheters Spectranetics Corporation Class III
Oral and maxillofacial cone beam computed tomography equipment Osstem Implant Co., Ltd. Class III
VENTANA HER2 Dual ISH DNA Probe Cocktail Roche Diagnostics GmbH Class III
INOmax DSIR Plus Delivery System Mallinckrodt Manufacturing LLC Class III
OsteoCool RF Ablation Electrode Medtronic Sofamor Danek USA, Inc. Class III
Disposable Vitrectome D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Class III
Electronic Biliary Endoscope 富士フイルム株式会社 Class II
MRI Contrast media injector Ulrich GmbH & Co.KG Class II
LA Control 积水医疗株式会社 Class II
INTEGRATED DEVICE CORNEAL ANALYZER AND OCULAR BIOMETER VISIA IMAGING S.r.l. Class II
Proxyt Paste for professional tooth cleaning Ivoclar Vivadent AG Class II
Introducer Sheath OSCOR INC. Class II
Auditory analysis platform PATH MEDICAL GmbH Class II
Infusomat Plus Line B.Braun Melsungen AG Class II
Sterile Latex Examination Glove HARTALEGA SDN. BHD. Class II
Disposable Retractor CooperSurgical, Inc. Class II
Surgical Incision Negative Pressure Drainage Dressing Kit KCI USA, Inc. Class II
iSR’obt Biopsy Kit Biobot Surgical Pte Ltd Class II
Total Protein_2 (TP_2) Siemens Healthcare Diagnostics Inc. Class II
Lumipulse® G Pepsinogen II Calibrators Fujirebio Inc. Class II
Patient Programmer Medtronic Inc. Class II
Reusable Patient Return Electrode Megadyne Medical Products Inc. Class II
aPTT Lupus Roche Diagnostics GmbH Class II
Continuous Wave 4 Arthroscopy Pump Arthrex,Inc. Class II
BIOPHEN Heparin LRT HYPHEN BioMed Class II
GEM ChemSTAT CVP 2 Instrumentation Laboratory Company Class II