CFDA issued the first batch product for Supervision and Random Checking of Medical Device Clinical Trial

In order to strengthen the management of medical device clinical trial, CFDA has started to check the authenticity and compliance of clinical trial data according to The Notice about Conducting the Supervision and Random Checking of Medical Device Clinical Trial. The first batch of supervision and random checking catalogue include 10 application items which are managed as Class III.
The detailed information as following:

The first batch of supervision and random checking catalogue

No.	Accepted No.	Product name	Applicant
1	準 15-1744	HEV-IgM/IgG Antibody Detection Kit(Colloidal gold method)	Xiamen Boson Biotech Co.,Ltd.
2	準 15-3145	Dialysis Concentrate	Tianjin Shenyouda Medical Device Co.,Ltd
3	準 15-2601	Multi-parameter Monitor	Guangdong Biolight Meditech Co., Ltd.
4	準 15-2788	HBeAg Reagent Kit（Chemiluminiscence）	Sichuan Maccura Biotechnology Co., Ltd.
5	準 15-1694	Angiographic X-ray System	Lepu Medical Technology (Beijing) Co., Ltd.
6	進15-4200	Modified Sodium Hyaluronate Gel for Injection	CROMA GmbH
7	進 15-1668	Murex HTLV I + II (Chemiluminescence Microparticle Immuno Assay）	Abbott GmbH & Co.KG
8	進 15-1679	Anti-soluble liver antigen antibody detection kit (EIA)	ORGENTEC Diagnostika GmbH
9	進 15-3790	Pt&Cr alloy elution coronary stent system with Everolimus	Boston Scientific Co., Ltd.
10	進 15-2682	Absorbable Collagen sponge Hemostatic	Bioland Co., Ltd.