China NMPA Newsletter – November 2023
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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 |
