13 Medical Device Companies in Guangdong Halted for GMP Non-compliance

May 04, 2024 17:20 CST Updated 17:20

Wanling Bangqiao

Ophthalmic Medical Device R&D, Production, and Sales

Guangdong Provincial Drug Administration

Notice

Issue No. 43, 2024

Recently, the Guangdong Provincial Medical Products Administration organized inspections of medical device manufacturers and found serious deficiencies in the quality management systems of the following 13 companies, which do not comply with the relevant regulations of the "Medical Device Production Quality Management Standards." The Guangdong Provincial Medical Products Administration has legally taken control measures to order the suspension of production.

Serial Number	Enterprise Name	Production License Number
1	Wanling Bangqiao Medical Equipment (Guangzhou) Co., Ltd.	Yue Food and Drug Administration Medical Device Production License No. 20183260
2	Guangdong Weiliming Technology Co., Ltd.	GDMPA Medical Device Manufacturing License No. 20224914
3	Shenzhen Hexin Chongdian Medical Equipment Co., Ltd.	Yue Food and Drug Administration Medical Device Production License No. 20020484
4	Shenzhen Ailite Medical Technology Co., Ltd.	Yue Food and Drug Administration Medical Device Production License No. 20122211
5	Shenzhen Suogan Technology Co., Ltd.	Yue Food and Drug Administration Medical Device Production License No. 20203537
6	Shenzhen Shengtong Technology Co., Ltd.	Registrant Entrusted Production
7	Shenzhen Jingchuang Technology Electronics Co., Ltd.	GDMPA Medical Device Production License No. 20224862
8	Shenzhen Shenxi Intelligence Co., Ltd.	Registrant Entrusted Production
9	Shenzhen Jiexin Medical Technology Co., Ltd.	Registrant Commissioned Production
10	Shenzhen Xinhua Jia Technology Co., Ltd.	GDMPA Medical Device Manufacturing License No. 20235228
11	Shenzhen Taikang Medical Equipment Co., Ltd.	Yue Food and Drug Administration Medical Device Production License No. 20183304
12	Guangdong Zhilian Xing Precision Technology Co., Ltd.	GDMPA Medical Device Manufacturing License No. 20245392
13	Guangdong Feiyu Medical Technology Co., Ltd.	Yue Food and Drug Administration Medical Device Production License No. 20193399

Hereby announced.

Guangdong Provincial Drug Administration

April 30, 2024

▲ Source of the article:Guangdong Province MedicinesSupervision and ManagementBureau

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