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NMPA New Approvals in August 2023
In August 2023, NMPA approved 288 medical devices, including 33 Class III imported products, 24 Class II imported products, and 229 Class III domestic products.
Below is a list of approved Class III and Class II imported products in August 2023.
| Medical Device/IVD | Manufacturer | Category |
| Heart-Lung Support System | Maquet Cardiopulmonary GmbH | Class III |
| Novasight Hybrid Catheter | Conavi Medical Inc. | Class III |
| MynxGrip Vascular Closure Devices | Cardinal Health | Class III |
| Preloaded Intraocular Lens | HOYA Medical Singapore Pte. Ltd. | Class III |
| 3M Tegaderm Silicone Foam Dressing | 3M Company | Class III |
| CPX4 PLUS Smooth Breast Tissue Expanders | Mentor | Class III |
| Aspheric Multifocal Lens | Teleon Surgical B.V | Class III |
| Intraocular lens | Carl Zeiss Meditec AG | Class III |
| TightRope | Arthrex,Inc. | Class III |
| GlidePath ™ Long-Term Hemodialysis Catheter | Bard Access Systems,Inc. | Class III |
| High Flux Dialyzer | Bellco S.r.l. | Class III |
| Palindrome Precision H Chronic Catheter | Covidien llc | Class III |
| Blank Cal | Roche Diagnostics GmbH | Class III |
| Ticron Coated Braided Polyester Nonabsorbable Suture | Covidien llc | Class III |
| FIBERGRAFT BG Putty Bone Graft Substitute | Prosidyan,Inc. | Class III |
| LIAISON XL murex HBsAg Quant | DiaSorin Italia S.p.A. | Class III |
| ORTHO Optix Reader | Ortho-Clinical Diagnostics | Class III |
| XVIVO Perfusion System | XVIVO Perfusion AB | Class III |
| IntraSight Integrated System | Volcano Corporation | Class III |
| Surgical Navigation System | Quantum Surgical SAS | Class III |
| Comprehensive Reverse Shoulder System | Zimmer Inc. | Class III |
| CD HORIZON Spinal System | Medtronic Sofamor Danek USA,Inc. | Class III |
| Tigertriever Revascularization Device | Rapid Medical Ltd. | Class III |
| Harmonize | Kerr Corporation | Class III |
| i-ED Coil | 株式会社カネカ | Class III |
| HOYA iSert Preloaded Intraocular Lens | HOYA Medical Singapore Pte. Ltd. | Class III |
| Affixus Natural Nail Humeral Nail System | Zimmer GmbH | Class III |
| Implant | Noris Medical Ltd. | Class III |
| Free Protein S | Roche Diagnostics GmbH | Class III |
| Plasma HF-resection electrodes | Olympus Winter & Ibe GmbH | Class III |
| Semi-Automated External Defibrillator | Physio-Control, Inc. | Class III |
| Infuse Bone Graft | Medtronic Sofamor Danek USA,Inc. | Class III |
| ENSEAL X1 Tissue Sealer | Ethicon Endo – Surgery,LLC | Class III |
| Built-in Scaler | E.M.S. Electro Medical Systems S.A. | Class II |
| Ambulatory Blood Pressure Recorder | SOMNOmedics GmbH | Class II |
| Endoscopes of Laparoscopy | KARL STORZ SE & Co. KG | Class II |
| DD medical zirconia and accessories | Dental Direkt GmbH | Class II |
| X-ray Tube Assemblies of Rotating Anode | Philips Medical Systems DMC GmbH | Class II |
| Intraoral Scanner | MEDIT Corp. | Class II |
| Orthodontic bracket | BIOCETEC Co., Ltd. | Class II |
| ENT MR8 Burs | Medtronic Powered Surgical Solutions | Class II |
| VITA LUMEX AC | VITA Zahnfabrik,H. Rauter GmbH & Co. KG | Class II |
| CalSet Androstenedione | Roche Diagnostics GmbH | Class II |
| cobas GLU QC kit | Roche Diagnostics GmbH | Class II |
| cobas GLU linearity kit | Roche Diagnostics GmbH | Class II |
| 3GEM ChemSTAT CVP 3 | Instrumentation Laboratory Company | Class II |
| TIPCAM1 Rubina | KARL STORZ SE & Co.KG | Class II |
| Electrically operated hospital bed with scales | LINET spol. s r.o. | Class II |
| FX Assay Kit (Coagulation Method) | Roche Diagnostics GmbH | Class II |
| Porcelain Etch Gel | Pulpdent Corporation | Class II |
| Sterile Protective Cover | Jiangxi 3L Medical Products Group (Cambodia) Co.,Ltd | Class II |
| FMS VUE II Fluid Management and Tissue Debridement System | Medos International SARL | Class II |
| FVII Assay Kit (Coagulation Method) | Roche Diagnostics GmbH | Class II |
| Image processing unit | オリンパスメディカルシステムズ株式会社 | Class II |
| Cercon ht ML | DeguDent GmbH | Class II |
| Dental Drills | Biomet 3i,LLC | Class II |
| Ultrasonic scaler | SATELEC A Company of ACTEON Group | Class II |
| Medical Device/IVD | Manufacturer | Category |
| Heart-Lung Support System | Maquet Cardiopulmonary GmbH | Class III |
| Novasight Hybrid Catheter | Conavi Medical Inc. | Class III |
| MynxGrip Vascular Closure Devices | Cardinal Health | Class III |
| Preloaded Intraocular Lens | HOYA Medical Singapore Pte. Ltd. | Class III |
| 3M Tegaderm Silicone Foam Dressing | 3M Company | Class III |
| CPX4 PLUS Smooth Breast Tissue Expanders | Mentor | Class III |
| Aspheric Multifocal Lens | Teleon Surgical B.V | Class III |
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China NMPA Releases the Results of Medical Device Sampling Inspections In order to strengthen the supervision and management of medical devices, and ensure that the quality of medical device products is safe and effective, NMPA usually conduct sampling inspection on medical devices in China. Recently, NMPA organized a product quality supervision and sampling inspection on five varieties of medical devices, including dental low voltage electric motors, patches (far infrared therapeutic patches, magnetic therapy patches, acupoints magnetic therapy patches). As per the sampling inspection results, a total of 12 lots (units) of products do not comply with the standards. |
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China NMPA Approves Tigertriever Revascularization Device for Market On August 17, 2023, NMPA approved for the registration application of the Tigertriever Revascularization Device manufactured by Rapid Medical Ltd. The product consists of a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. Its proximal and distal ends are each fitted with a 90% platinum/10% iridium alloy developer marker. The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA), or who fail IV t-PA therapy, are candidates for treatment. |
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NMPA Updated Medical Device Classification Catalog (No. 101 of 2023) In accordance with the relevant requirements of the Regulations for the Supervision and Administration of Medical Devices (Order 739) and the Procedures for Dynamic Adjustment of the Medical Device Classification Catalog, NMPA is adjusting Medical Device Classification Catalog periodically. |
Resources – Webinar/Short Videos
Please click here to review the record of BradyKnows webinar and short videos.
- Revisiting 2022 And Looking Into 2023: Regulatory Updates For Medical Device Market Access In China
- Keep Up With The Trend Of Medical Devices Localization In China: Background, Policy, Regulation, And Case Study
- What is Hainan Boao Lecheng International Medical Tourism Pilot Zone?
- What Can International Medical Device Manufacturer Do in Hainan Medical Tourism Pilot Zone?
- Hainan Urgent Use Program for International Medical Device Manufacturers
- China’s Medical Device Clinical Evaluation Pathways
- Real-World Evidence for NMPA Premarket Clinical Evaluation
- Faster China NMPA Approval via Real-World Study in Hainan
- Commercial & Regulatory Benefits of Entering Hainan Pilot Zone
- Usage of Real-World Evidence for Medical Devices China vs. US
Resources – New Documents Download
- Provisions For The Supervision And Administration Of Drug Manufacturing(July 1, 2020)
- Good Supply Practice For Drugs(June 30, 2016)
- Provisions For The Lot Release Of Biological Products(March 1, 2021)
- Provisions For Crude Drugs Importation(May 16, 2019)
- The Provisions For Registration And Filing Of Cosmetics(May 1, 2021)
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