On March 14, 2023, the NMPA issued the 45th batch of information on medical device approvals, including 9 new registration approvals with 5 new imported medical devices and 4 new domestic medical devices. Details are listed as below.
No. | Product Name | Applicant | Approval Data |
1 | Emergency and Transport Ventilator | Shenzhen Comen Medical Instrument Co., Ltd. | 2023-03-13 |
2 | Cerebrovascular Interventional Surgery Assist Operating System | Yidu Hebei Robot Tech Co., Ltd. | 2023-03-13 |
3 | High frequency surgical equipment | Xinjing Yunying Medical Technology (Zaozhuang) Co., Ltd. (BradyKnows Zaozhuang Company) | 2023-03-13 |
4 | Emergency and Transport Ventilator | ShenZhen HarveyMed Co., Ltd. | 2023-03-13 |
5 | Ceramic Self-ligating Bracket | 3M Company | 2023-03-14 |
6 | Urology Endoscope And Accessories | SCHÖLLY FIBEROPTIC GMBH | 2023-03-13 |
7 | Intraoral Imaging Dental X-ray Machine | VATECH Co., Ltd. | 2023-03-13 |
8 | LC MS System | Agilent Technologies Singapore (International) Pte. Ltd. | 2023-03-13 |
9 | UF Heparin Control | HYPHEN BioMed | 2023-03-13 |
Xinjing Yunying Medical Technology (Zaozhuang) Co., Ltd. is a subsidiary of BradyKnows (BradyKnows Zaozhuang Company), focusing on high-frequency surgical equipment, accessories and other electrosurgical devices. In addition, BradyKnows Zaozhuang Company is a localization base for overseas medical device manufacturers to help our clients enter China faster and aim to support global distribution.
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
Sources: NMPA