Source: Jiangsu Provincial Drug Administration

According to the “Regulations on the Supervision and Administration of Medical Devices” and the “Management Standards for the Quality Management of Medical Devices” and other relevant regulations, the Jiangsu Provincial Drug Administration from May 10 to June 18, 2021 There are many complaints and reports, 34 medical device manufacturers that have not carried out quality system self-inspection or self-inspection of zero defects, and poor quality system operation, etc., have conducted cross unannounced inspections. After inspection and risk consultation, the following 11 companies need to suspend production for rectification (4 of them have ceased production before the cross-flying inspection).

They are:

1. Nanjing Sellkin Biomedical Co., Ltd.

2. Nanjing Nanya Medical Equipment Co., Ltd. (Production stopped before the cross-flight inspection)

3. Suzhou Health Online Medical Technology Co., Ltd. (Production stopped before the cross-flight inspection)

4. Danyang Kangbao Medical Technology Co., Ltd.

5. Changzhou Chunguang Medical Equipment Co., Ltd.

6. Wuxi Tongda Medical Electrical Appliance Co., Ltd.

7. Jiangsu Sudun Biomedical Technology Co., Ltd.

8. Yangzhou Zhengyu Medical Equipment Co., Ltd. (Production stopped before the cross-flight inspection)

9. Taizhou Blue Bay Medical Equipment Co., Ltd.

10. Jiangsu Zhihai Electronic Technology Co., Ltd. (Production stopped before the cross-flight inspection)

11. Jiangsu Hongxin Medical Technology Co., Ltd.

After the above-mentioned enterprises have completed their rectification and reform, they must be reviewed and qualified by our bureau and announced before they can resume production.

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