NMPA New Approvals In February 2023


In February 2023, NMPA approved 162 medical devices, including 19 Class III imported products, 22 Class II imported products, and 120 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 February 2023.

Medical Device/IVD Manufacturer Category
OR3O Dual Mobility System Smith & Nephew, Inc. Class III
AOSept Plus with HydraGlyde lens case solution Alcon Laboratories, Inc. Class III
V-Loc 180 Absorbable Wound Closure Device Covidien llc Class III
HOYA iSert Preloaded Intraocular Lens HOYA Medical Singapore Pte. Ltd. Class III
Aspiration catheter Genoss Co., Ltd. Class III
Dextile™ Anatomical Mesh Sofradim Production Class III
Railway Sheathless Access System Cordis Corporation Class III
Endoscopic Linear Cutter Reload Kits with Gripping Surface Technology Ethicon Endo-Surgery, LLC Class III
Healix Advance SP BIOCOMPOSITE Anchor Medos International SARL Class III
Prismaflex ST Set Gambro Industries Class III
Cardioblate Surgical Ablation System Medtronic Inc. Class III
Rotor-Gene Q MDx Analytik Jena AG Class III
CEREBASE DA Guide Sheath Medos International SARL Class III
FAST-FIX FLEX Smith & Nephew Inc. Endoscopy Division Class III
Hemodialysis System Fresenius Medical Care AG & Co.KGaA Class III
OCTARAY Mapping Catheter with TRUEref Technology Biosense Webster, Inc. Class III
Total Knee System-Tibial baseplate b-ONE Ortho, Corp. Class III
MOBIO™ Total Knee System-Femoral Condyle b-ONE Ortho, Corp. Class III
Hybrid Closed Loop Insulin Delivery System Medtronic MiniMed Class III
CEREC Zirconia+ DeguDent GmbH Class II
Endoscopic Accessories AMNOTEC International Medical GmbH Class II
Solo Hydro Hybrid Guidewire Heraeus Medical Components, LLC Class II
InnovEyes Sightmap WaveLight GmbH Class II
Vision testing instrument 株式会社トプコン Class II
MorSafe® Tissue Morcellation Bag Veol Medical Technologies Pvt. Ltd Class II
Video Upper GI Scope HOYA株式会社 Class II
Video Bronchoscope HOYA株式会社 Class II
Video endoscope 富士フイルム株式会社 Class II
Video endoscope 富士フイルム株式会社 Class II
Reusable laser fibres LISA Laser Products GmbH Class II
Video Upper GI Scope 富士フイルム株式会社 Class II
BIOPHEN UFH Calibrator HYPHEN BioMed Class II
BIOPHEN LMWH Control Plasma HYPHEN BioMed Class II
Endoscope Reprocessor CANTEL MEDICAL (ITALY)SRL Class II
Dosimetry Systems IBA Dosimetry GmbH Class II
Mammography Images Processing Software Siemens Healthcare GmbH Class II
Camera Head HOYA株式会社 Class II
Somnograph SOMNOmedics GmbH Class II
BIOPHEN Heparin Calibrator HYPHEN BioMed Class II
VITROS XT 7600 Integrated System Ortho-Clinical Diagnostics, Inc. Class II
Dental Implant Surgical Drill HAENAEM Co., Ltd. Class II