NMPA New Approvals In December 2022
In December 2022, NMPA approved 339 medical devices, including 37 Class III imported products, 25 Class II imported products, and 273 Class III domestic products. A total of 2,500 medical device products were approved by NMPA in 2022.
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 December, 2022.
| Medical Device/IVD | Manufacturer | Category |
| Emprint™ Ablation System with Thermosphere™ Technology | Covidien llc | Class III |
| Single Photon Emission Computed Tomography System | Spectrum Dynamics Medical Ltd. | Class III |
| Insulin Pump | SOOIL Development Co., Ltd | Class III |
| HIV Ag/Ab Combo (CHIV) Assay | Siemens Healthcare Diagnostics Inc. | Class III |
| Anesthesia System | MAQUET CRITICAL CARE AB | Class III |
| Phacomeulsification/Vitrectomy system and accessories | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | Class III |
| HemosIL Normal Control Assayed | Instrumentation Laboratory Company | Class III |
| Medical X-Ray angiography equipment | GE MEDICAL SYSTEMS SCS | Class III |
| nGEN™ Generator | Biosense Webster (Israel) Ltd. | Class III |
| Disposable Syringe Needle | Feel Tech Co., Ltd. | Class III |
| Prowler Select Plus Infusion Catheter | Medos International SARL | Class III |
| RapidVit™ Omni media for vitrification | Vitrolife Sweden AB | Class III |
| LifeStent 5F Vascular Stent System | Angiomed GmbH & Co. Medizintechnik KG | Class III |
| Ranger / Ranger SL Over-The-Wire Paclitaxel- Coated PTA Balloon Catheter | Hemoteq AG | Class III |
| Microcoil System | Medos International SARL | Class III |
| Auxiliary articulation tube | Atos Medical AB | Class III |
| Soft (Hydrophilic) Contact Lens | CooperVision Inc. | Class III |
| AngioSculpt PTA Scoring Balloon Catheter | Spectranetics Corporation | Class III |
| Delta Xtend Reverse Shoulder System | DePuy (Ireland) | Class III |
| Angiographic Catheter | ANGIODYNAMICS,INC. | Class III |
| Cordis Angiographic Needle | Cordis Cashel | Class III |
| Multipurpose I.V.Connection System | VYGON | Class III |
| One-Link | Baxter Healthcare SA | Class III |
| TECNIS Synergy OptiBlue Intraocular Lens | Johnson & Johnson Surgical Vision, Inc. | Class III |
| CLYDESDALE PTC Spinal System | Medtronic Sofamor Danek USA, Inc. | Class III |
| V.A.C.VERAFLO Dressing Kit | KCI USA, Inc. | Class III |
| Cochlear Implants | MED-EL Elektromedizinische Geräte GmbH | Class III |
| Implantable Pacemaker | Medtronic Inc. | Class III |
| Peripheral Coil System | MicroVention,Inc. | Class III |
| Infant radiation warming table | アトムメディカル株式会社 | Class III |
| Sterile pen needles for single use | Novo Nordisk A/S | Class III |
| Microcatheter System | テルモ·クリニカルサプライ株式会社 | Class III |
| Lumipulse® HBcrAg Controls | Fujirebio Inc. | Class III |
| Cranial surgical navigation and positioning system | Medtronic Navigation, Inc. | Class III |
| cobas® Buffer Negative Control Kit | Roche Diagnostics GmbH | Class III |
| TrapLiner catheter | Vascular Solutions LLC | Class III |
| Teeth Whitening Gel | Nanova Biomaterials, Inc. | Class III |
| Response Reader Advanced System | Response Biomedical Corporation | Class II |
| Valleylab Smoke Evacuation Rocker Switch Pencil | Covidien llc | Class II |
| OMNI II Programmer | Impulse Dynamics (USA), Inc. | Class II |
| Flexible Video-Cystoskop HD | KARL STORZ SE & Co.KG | Class II |
| Calibrator sTfR II | Roche Diagnostics GmbH | Class II |
| Seramun SpotSight® plate mono | Seramun Diagnostica GmbH | Class II |
| Amber Mill Blocks & Disks | HASS CORPORATION | Class II |
| Dissecting Tools | Medtronic Powered Surgical Solutions | Class II |
| The Electric Stealth-Midas MR8 System | Medtronic Powered Surgical Solutions | Class II |
| Implant Handpiece-Contra-angle | KaVo Dental GmbH | Class II |
| Audio Processor | MED-EL Elektromedizinische Geräte GmbH | Class II |
| Laser systems for patient alignment | LAP GmbH Laser Applikationen | Class II |
| LIAISON® XS | DiaSorin S.p.A. | Class II |
| X-ray flat panel detector | キヤノン電子管デバイス株式会社 | Class II |
| Mammography X-ray unit | Planmed Oy | Class II |
| EmbryoScope Flex | Vitrolife A/S | Class II |
| EmbryoScope Flex | Vitrolife A/S | Class II |
| Patient Programmer | Medtronic Inc. | Class II |
| Patient Table | Dornier MedTech GmbH | Class II |
| BIS Extend sensor | Covidien llc | Class II |
| Portable X-ray system | Osstem Implant Co., Ltd. | Class II |
| McGRATH MAC Video Laryngoscope | Aircraft Medical Limited | Class II |
| BIOPHEN LMWH Control Low | HYPHEN BioMed | Class II |
| eG1 Cutting Tips | The Anspach Effort, Inc. | Class II |
| aTgII Quality Control (aTgII QC) | Siemens Healthcare Diagnostics Products Limited | Class II |
