China NMPA Newsletter – November 2023


2023-12-31


Featured Articles


NMPA New Approvals in November 2023

In November 2023, NMPA approved 301 medical devices, including 34 Class III imported products, 39 Class II imported products, and 226 Class III domestic products.

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

Medical Device/IVD Manufacturer Category
Proton Therapy System Varian Medical Systems Particle Therapy GmbH & Co. KG Class III
Amplatzer Talisman PFO Occluder Abbott Medical Class III
Amplatzer Talisman Delivery Sheath Abbott Medical Class III
CONTACT LENSES Supervision Optimax Sdn Bhd Class III
Arctic Sperm Cryopreservation Medium FUJIFILM Irvine Scientific, Inc. Class III
Anchored balloon dilatation catheter 株式会社カネカ Class III
Dual-curing bonding resin watermend Tokuyama Dental Corporation Class III
SU-POR Patient-Specific Surgical Implant Poriferous, LLC Class III
Sterile Silicone Breast Implants Motiva Implant Matrix Establishment Labs S.A. Class III
ProTi360°Interbody System Tyber Medical, LLC Class III
MP Monoblock Hip Prosthesis Stem Waldemar Link GmbH & Co. KG Class III
ROTAPRO Rotational Atherectomy System Boston Scientific Corporation Class III
Diagnostic Ultrasound System GE Healthcare Austria GmbH & Co OG Class III
ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device Boston Scientific Corporation Class III
SPECT/CT Spectrum Dynamics Medical Ltd. Class III
Precision1 for Astigmatism soft contact lenses Alcon Laboratories, Inc. Class III
Clareon PanOptix Trifocal Hydrophobic IOL Alcon Laboratories, Incorporated Class III
Continuous Single Culture® Complete (CSCM-C) FUJIFILM Irvine Scientific, Inc. Class III
Soft Tissue Implants Visco-elastic gel of hyaluronic acid – with lidocaine Laboratoires Fill-Med Manufacturing S.A. Class III
pORTAL Steerable Hydrophilic Guidewire phenox GmbH Class III
AngioSculpt PTCA Scoring Balloon Catheter, Rapid Exchange (RX) Philips Image Guided Therapy Corporation Class III
ACTIS DuoFix Hip Prosthesis DePuy (Ireland) Class III
ETHIBOND Excel Polyester Suture with Pledget Ethicon, LLC Class III
3M Tegaderm High Performance Foam Non-Adhesive Dressing 3M Company Class III
BIOCLEN O2 SEPT OPHTECS CORPORATION Class III
PEEK Suture Anchor Arthrex, Inc. Class III
ETHIBOND Excel Polyester Suture with Pledget Ethicon, LLC Class III
Continuous Glucose Monitoring System Abbott Diabetes Care Ltd. Class III
SpaceStation and SpaceCom B. Braun Melsungen AG Class III
StarWalker Fotona d.o.o. Class III
cobas® 5800 Instrument Roche Molecular Systems, Inc. Class III
Patient monitor GE Medical Systems Information Technologies, Inc. Class III
RGP ASPHERIC Lens Fitlens Ltd Class III
Steerable guiding sheath Oscor Inc. Class III
Accu-Chek Guide Link blood glucose meter Roche Diabetes Care GmbH Class II
Free Beta Human Chorionic Gonadotropin (FBHCG) Siemens Healthcare Diagnostics Inc. Class II
Pulse CO-Oximeter Masimo Corporation Class II
Medical Images Processing Software Siemens Healthcare GmbH Class II
Pregnancy-Associated Plasma Protein-A (PAPP-A) Siemens Healthcare Diagnostics Inc. Class II
Haptoglobin assay kit (Immunoturbidimetric method) Siemens Healthcare Diagnostics Inc. Class II
Liquichek Immunology Control Bio-Rad Laboratories, Inc. Class II
Squamous Cell Carcinoma Calibrator (SCC CAL) Siemens Healthcare Diagnostics Inc. Class II
N Protein Standard UY Siemens Healthcare Diagnostics Products GmbH Class II
Uriflet S 11UA ARKRAY Factory, Inc. Class II
Video Duodenoscope HOYA株式会社 Class II
Ophthalmoscope Fundus Camera CenterVue S.p.A. Class II
Uro-3500 Display Handle Kit UroViu Corporation Class II
Flexible Endoscope, Single-use Ambu A/S Class II
Disposable biopsy forceps オリンパスメディカルシステムズ
株式会社
Class II
CEREC Tessera DeguDent GmbH Class II
Attachments bredent GmbH & Co. KG Class II
DAMON ULTIMA ARCHWIRES Ormco Corporation Class II
Transnasal Feeding Tube Fresenius Kabi AG Class II
DAMON ULTIMA ARCHWIRES Ormco Corporation Class II
Surgical Instrument Kit MegaGen Implant Co.,Ltd. Class II
Electric Traction Chair オージー技研株式会社 Class II
SleepImage System MyCardio LLC Class II
Autophoropter ESSILOR INTERNATIONAL Class II
Diagnostic Ultrasound System GE Vingmed Ultrasound A/S Class II
Cholinesterase assay kit (butyrylthiocholine substrate method) Siemens Healthcare Diagnostics Inc. Class II
Battery Power Supply Surgical Equipment for Osseous Tissue Synthes GmbH Class II
CalSet FT4 IV Roche Diagnostics GmbH Class II
Attachments bredent GmbH & Co. KG Class II
Dental Zirconia Porcelain Powder 株式会社松風 Class II
Bright Impress Genoss Co., Ltd. Class II
Kangaroo Connect Enteral Feeding Sets Covidien llc Class II
Surgipro II Monofilament Polypropylene Nonabsorbable Suture with CARDIOPOINT Cardiovascular Needles Covidien llc Class II
Condensation Silicones for Dental Impression ZHERMACK S.p.A Class II
Lupus S Roche Diagnostics GmbH Class II
FLUID CONTROL 2225 Richard Wolf GmbH Class II
Acid Oxidation Potential Water Generator アマノ株式会社 Class II
myoelectric evoked potentials (EMG) 日本光電工業株式会社 Class II
Comprehensive Dental Treatment Machines Dentium Co., Ltd. Class II

China’s State Council Approves Blueprint for Beijing’s National Service Industry Pilot Zone

In a monumental decision, China’s State Council has officially given the nod to the ambitious plan for constructing the National Service Industry Pilot Zone in Beijing on November 23, 2023. The document charts a course to deepen the development of the national service industry and enhance its global openness—a move that BradyKnows Medical recognizes as a significant leap forward.

 

China Approves Innovative Single-Port Laparoscopic Surgery System

On November 24, 2023, the NMPA granted approval for the innovative “Single-Incision Laparoscopic Surgery System.

 

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