China NMPA announced the following enterprises whose applications fully comply with the prerequisite criteria and are accepted into the special review process of innovative medical device and priority review of medical device, respectively.

Approved Applications for Special Review of Innovative Medical Devices

Product name: Self-expandable Aneurysm Embolization System (自膨式动脉瘤瘤内栓塞系统)
Applicant: Sequent Medical, Inc.

Product name: Oxidized Regenerated Cellulose Hemostatic Powder (再生氧化纤维素可吸收止血粉)
Applicant: Ethicon LLC

Product name:  Cardiac cryoablation system (心脏冷冻消融系统)
Applicant: Kangfeng Biotechnology (Shanghai) Co., Ltd

Product name: Aortic Stent Graft System (主动脉覆膜支架破膜系统) Applicant: LifeTech Scientific (Shenzhen) Limited Company

Approved Applications for the Priority Review of Medical Devices

Code	Product name	Applicant	Approved reason
CSZ1900206	Hepatitis B virus pgRNA (HBV-pgRNA) assay kit (PCR-fluorescence probe method) 乙型肝炎病毒pgRNA(HBV-pgRNA)测定试剂盒（PCR-荧光探针法）	Hotgen Biotech Co.,Ltd	This medical device is listed and included as the national science and technology major projects.
CSZ1900199	Newborn screening for non-derivative multiple genetic metabolic diseases (tandem mass spectrometry) 非衍生化多种新生儿遗传代谢病筛查试剂盒（串联质谱法）	Suzhou Sym-Bio Life Science Co.,Ltd.	This medical device is used to treat rare disease, and clearly demonstrate clinical benefits

 

Published on Jun 28, 2019