NMPA New Approvals In January 2023
In January 2023, NMPA approved 124 medical devices, including 11 Class III imported products, 12 Class II imported products, and 99 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 January 2023.
| Medical Device/IVD | Manufacturer | Category |
| Cardiac Resynchronization Device Tiered-therapy Cardioverter/Defibrillator | St. Jude Medical Coordination Center BVBA | Class III |
| Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | Class III |
| BD Vacutainer® Safety-Lok™ Blood Collection Set | Becton Dickinson and Company | Class III |
| Belotero Volume Lidocaine | Anteis SA | Class III |
| Athletis OVER-THE-WIRE PTA Balloon Dilatation Catheter | Boston Scientific Corporation | Class III |
| Restylane Volyme | Q-Med AB | Class III |
| TiBases and Screws | Zfx GmbH | Class III |
| Medical X-Ray angiography equipment | GE MEDICAL SYSTEMS SCS | Class III |
| Diagnostic Ultrasound System | ESAOTE S.p.A. | Class III |
| Ultrasound Diagnostic Equipment | SUPERSONIC IMAGINE | Class III |
| Cardiac Resynchronization Device Tiered-therapy Cardioverter/Defibrillator | St.Jude Medical Coordination Center BVBA | Class III |
| Dissecting Tools | Medtronic Powered Surgical Solutions | Class II |
| Riptide™ Large Bore Aspiration Tubing | Micro Therapeutics, Inc.DBA ev3 Neurovascular | Class II |
| Vertebroplasty Adjuncts | Seawon Meditech Co., Ltd. | Class II |
| Subcyclo Probe | QUANTEL MEDICAL | Class II |
| HDL Cholesterol Calibrator (HDLC CAL) | Siemens Healthcare Diagnostics Inc. | Class II |
| QUANTA-Lyser 3000 ELISA/IFA + Incubator | INOVA Diagnostics, Inc. | Class II |
| Automatic air mattress systems | Care of Sweden AB | Class II |
| Mobile ECG Atrial Fibrillation Alert Software | 삼성전자(주) | Class II |
| Wrist0x2 Pulse 0ximeter | Nonin Medical,Inc. | Class II |
| Diagnostic X-Ray tube | VAREX IMAGING CORPORATION | Class II |
| Skater Fix | Argon Medical Devices, Inc. | Class II |
| Aqua Maris® Strong nasal spray | Jadran-Galenski laboratorij d.d. | Class II |
