NMPA Released The 45th Batch Of Medical Device Approvals For 2023


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