NMPA New Approvals In July 2022
In July 2022, NMPA approved 197 medical devices, including 20 Class III imported products, 22 Class II imported products, and 152 Class III domestic products.
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 July, 2022.
| Medical Device/IVD | Manufacturer | Category |
| Breast Implant | Mentor | Class III |
| Vascular Stent Graft | Angiomed GmbH & Co. Medizintechnik KG | Class III |
| Medical X-ray angiography equipment | GE MEDICAL SYSTEMS SCS | Class III |
| Hemodynamic and Electrophysiological Recording System | Siemens Healthcare GmbH | Class III |
| Cochlear implant | Advanced Bionics AG | Class III |
| Biodentine | SEPTODONT | Class III |
| Sterile siliconised needles | SEPTODONT | Class III |
| Ophthalmic Photocoagulator | Lumenis Inc. | Class III |
| Ear nose X-ray cone beam tomography equipment | Xoran Europe D.o.o | Class III |
| Catheter sheath system | 東郷メディキット株式会社 | Class III |
| Hip Joint Prostheses-Acetabular Liner | Zimmer Inc. | Class III |
| Hip Joint Prostheses-Acetabular Liner | Zimmer Inc. | Class III |
| Hydrophilic coated guide catheter | PendraCare International B.V. | Class III |
| Semiconductor laser hair remover | Formatk Systems Ltd. | Class III |
| Implantable Pacemaker | Medtronic Inc. | Class III |
| Syringe kits for drug mixing | MEDEX | Class III |
| Special needle for disposable implantable drug delivery device | pfm medical cpp SA | Class III |
| Double curing resin cement | VERICOM CO., LTD. | Class III |
| Ureteral stents and sets | Urotech GmbH | Class III |
| Implantable deep brain nerve stimulator | Medtronic Inc. | Class III |
| Small Bone Powered Surgical Systems | Stryker Instruments | Class II |
| Disposable electronic bronchoscope | Ambu A/S | Class II |
| Digital mobile photographic X-ray machine | 富士フイルム株式会社 | Class II |
| Shock wave therapeutic apparatus | (주) 한일 티엠 | Class II |
| Creatinine and urea nitrogen electrodes | Nova Biomedical Corporation | Class II |
| Disposable heated breathing tube | Drägerwerk AG & Co. KGaA | Class II |
| Body composition analyzer | AKERN SRL | Class II |
| EEA Circular Stapler with Tri-Staple Technology | Covidien llc | Class II |
| Disposable Foley Catheters | ConvaTec Limited | Class II |
| Disposable Trocar | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | Class II |
| Electric peeling machine | Aesculap AG | Class II |
| Lower limb medical rehabilitation training apparatus | ArjoHuntleigh AB | Class II |
| Monitoring information management software | Philips Medizin Systeme Böblingen GmbH | Class II |
| Seawater nasal spray | Jadran-Galenski laboratorij d.d. | Class II |
| Puncture instrument and accessories for laparoscope | AMNOTEC International Medical GmbH | Class II |
| Ultrasonic scaler | SATELEC A Company of ACTEON Group | Class II |
| Multiconstituent Calibrator | Siemens Healthcare Diagnostics Inc. | Class II |
| Dental diaphragms | Bay Materials LLC | Class II |
| Drills | WARANTEC CO., Ltd. | Class II |
| Multi-test control | Bio-Rad Laboratories, Inc. | Class II |
| Embryo incubator | Planer Limited | Class II |
| Infusion pump | AMPALL CO.,Ltd | Class II |
