In December 2023, NMPA approved 343 medical devices, including 37 Class III imported products, 38 Class II imported products, and 266 Class III domestic products.
China NMPA is constantly upgrading regulations and guidelines for medical device regulatory, clinical affairs and post market surveillance in latest years. BradyKnows elite team has extensive experiences to support the whole life cycle of medical device. 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 December 2023.
| Medical Device/IVD | Manufacturer | Category |
| DG Reader Net | Diagnostic Grifols, S.A. | Class III |
| Implantable pacemakers | St. Jude Medical Cardiac Rhythm Management Division | Class III |
| Implantable Sacral Neurostimulation Lead | Medtronic Inc. | Class III |
| IV Filters | Pall Medical, a Division of Pall International Sàrl | Class III |
| Polydioxanone suture | Search Medical Co., Ltd. | Class III |
| Trimark Breast Tissue Marker | Hologic, Inc. | Class III |
| TRUSELECT Microcatheter | Boston Scientific Corporation | Class III |
| Modified Sodium Hyaluronate Gel for Injection with Lidocaine | YooYoung Pharmaceutical Co., Ltd. | Class III |
| MitraClip G4 Clip Delivery System | Abbott Medical | Class III |
| Coronary Intervention Control System | Robocath S.A.S | Class III |
| Implantable Cardioverter Defibrillator | Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation | Class III |
| ArtiSential Multi-joint Laparoscopic Electrosurgical Instruments | LivsMed Inc. | Class III |
| Ophthalmic Nd:YAG laser treatment machine | 株式会社ニデック | Class III |
| Implantable Cardioverter Defibrillator | Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation | Class III |
| NEO Iris | Immucor Medizinische Diagnostik GmbH | Class III |
| Precision7 Soft Contact Lenses | Alcon Laboratories, Inc. | Class III |
| Contrast Injector Hose System | ulrich GmbH & Co.KG | Class III |
| PROLENE Polypropylene Nonabsorbable suture with Pledget | Ethicon, LLC | Class III |
| PROLENE Polypropylene Nonabsorbable Suture with Pledget | Ethicon, LLC | Class III |
| GUIDESTAR Steerable Guiding Sheath | Oscor Inc. | Class III |
| Meniscal Repair Device – FiberStitch | T.A.G. Medical Products Corporation Ltd. | Class III |
| MitraClip G4 Steerable Guide Catheter | Abbott Medical | Class III |
| Arthrex Suture | Arthrex, Inc. | Class III |
| PreciControl HBsAg Auto Confirm | Roche Diagnostics GmbH | Class III |
| MammaTyper® | BioNTech Diagnostics GmbH | Class III |
| Vesta Charger | Impulse Dynamics （USA）, Inc. | Class III |
| Blood Parameter Monitoring System | Terumo Cardiovascular Systems Corporation | Class III |
| X-ray Angiography System | Siemens Healthcare GmbH | Class III |
| Implantable Cardioverter Defibrillator | Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation | Class III |
| ICP Sensor Kits | Integra LifeSciences Production Corporation | Class III |
| TurboHawk Plus Directional Atherectomy System | Medtronic, Inc. | Class III |
| ILLUMISITE Endobronchial Procedure Kit | Covidien llc | Class III |
| Dental Implant | Nobel Biocare AB | Class III |
| Proton Therapy System | Varian Medical Systems Particle Therapy GmbH & Co. KG | Class III |
| HemosIL Special Test Control Level 2 | Instrumentation Laboratory Company | Class III |
| BLOOD MONITORING UNIT | Eurosets s.r.l. | Class III |
| HemosIL Special Test Control Level 1 | Instrumentation Laboratory Company | Class III |
| Helioseal F Plus | Ivoclar Vivadent AG | Class II |
| PreludeSYNC DISTAL™ Radial Compression Device | Merit Medical Systems,Inc. | Class II |
| anti-caries gel | （주） 해림덴텍 | Class II |
| Light-curing temporary restorative material | Ivoclar Vivadent AG | Class II |
| Glucose QC | （주）올메디쿠스 | Class II |
| Alinity i STAT CK-MB Reagent Kit | Abbott Ireland Diagnostics Division | Class II |
| Alinity i STAT CK-MB Calibrators | Abbott Ireland Diagnostics Division | Class II |
| Ophthalmic Image Management Software | 株式会社トプコン | Class II |
| SpyGlass Retrieval Basket | Boston Scientific Corporation | Class II |
| DUPLOSPRAY MIS APPLICATOR | Micromedics, Inc. | Class II |
| CoreDx Pulmonary Mini-Forceps | Boston Scientific Corporation | Class II |
| UNIUM & ACRION Saw Blades | Gebr. Brasseler GmbH & Co. KG | Class II |
| Zirconia Ceramic Blocks | VITA Zahnfabrik H. Rauter GmbH & Co. KG | Class II |
| SpyGlass Discover Digital Controller | Boston Scientific Corporation | Class II |
| D-10 Hemoglobin Testing System | Bio-Rad Laboratories, Inc. | Class II |
| HemosIL D-Dimer HS 500 Controls | Instrumentation Laboratory Company | Class II |
| Endoscopes and Accessories | Medos International SARL | Class II |
| Dental unit | DIPLOMAT DENTAL s.r.o. | Class II |
| PLASMA & STEM CELL THAWER | KW APPARECCHI SCIENTIFICI S.R.L. | Class II |
| Damon Ultima Bracket | Ormco Corporation | Class II |
| Cancer Antigen CA125 Calibrator | 東ソー株式会社 | Class II |
| InMotion ARM | Bionik,Inc. | Class II |
| Ophthalmic Surgical Microscope | 株式会社タカギセイコー | Class II |
| Tina-quant β2-Microglobulin（B2MG） | Roche Diagnostics GmbH | Class II |
| SpyGlass Discover Digital Catheter | Boston Scientific Corporation | Class II |
| Cannula G | UroViu Corporation | Class II |
| PFM alloy | The Argen Corporation | Class II |
| Automatic Blood and Body Fluid Analyzer | シスメックス株式会社 | Class II |
| Lupus C | Roche Diagnostics GmbH | Class II |
| Medical device imaging software in the clinical domain of cardiology | ADAS3D Medical S.L. | Class II |
| Chromatic VRE | Liofilchem S.r.l. | Class II |
| Alinity c Fructosamine Calibrator Kit | SENTINEL CH. S.p.A. | Class II |
| Squamous Cell Carcinoma (SCC) | Siemens Healthcare Diagnostics Inc. | Class II |
| Alinity i Anti-Tg Calibrators | Abbott Ireland Diagnostics Division | Class II |
| Alinity i Anti-TPO Calibrators | Abbott Ireland Diagnostics Division | Class II |
| Alinity i Anti-Tg Reagent Kit | Abbott Ireland Diagnostics Division | Class II |
| Disposable Scissor Pliers | オリンパスメディカルシステムズ株式会社 | Class II |
| Arthroscopy Instruments | DePuy Mitek | Class II |
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