# China NMPA Inspection - Yinjing Medical Technology (Shanghai) Co., Ltd. - December 07, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/yinjing-medical-technology-shanghai-co-ltd/479508cf-c4df-4bf1-bfa9-445cbcf9cbae/
Source feed: China

> China NMPA unannounced inspection for Yinjing Medical Technology (Shanghai) Co., Ltd. published December 07, 2017. An unannounced inspection of Jiaheng Medical Technology (Shanghai) Co., Ltd. was conducted on November 23, 2017, under the regulatory framework of Goo

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiaheng Medical Technology (Shanghai) Co., Ltd.
- Company Name: Yinjing Medical Technology (Shanghai) Co., Ltd.
- Publication Date: 2017-12-07
- Product Type: Device
- Summary: An unannounced inspection of Jiaheng Medical Technology (Shanghai) Co., Ltd. was conducted on November 23, 2017, under the regulatory framework of Good Manufacturing Practice for Medical Devices. The inspection revealed critical compliance issues, stemming from a production suspension initiated in 2015 following a failed on-site inspection for a production license address change. Investigators found no factory buildings at the company's licensed production address. Furthermore, the reported new address was found to be largely inactive, with only one employee present, confirming the company's continued operational suspension. This suspension had been consistently noted in follow-up inspections by the Qingpu District Market Supervision Administration in 2015, 2016, and 2017, with the company acknowledging its status and planning for future rectification. To resume production of its Medical Digital X-ray Imaging System, Jiaheng Medical Technology must obtain both a production license address change permit and a renewal registration permit for its product. These steps, along with a written report, must be submitted to the Shanghai Municipal Food and Drug Administration. Production can only recommence after the Municipal Administration conducts a confirming inspection and verifies full compliance, subsequently informing the State Administration for Market Regulation of the company's operational status.

Company: https://www.globalkeysolutions.net/companies/yinjing-medical-technology-shanghai-co-ltd/34e35b4d-7aae-42bf-b791-6f38854e3d70/