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Announcement of the second batch of national flight inspection ten companies to rectify within a time limit

Announcement of the second batch of national flight inspection ten companies to rectify within a time limit

  • Categories:Industry News
  • Author:
  • Origin:Ozida
  • Time of issue:2021-07-22
  • Views:0

(Summary description)In order to strengthen the supervision and management of medical devices and ensure the safety and effectiveness of medical devices, in accordance with the "Regulations on the Supervision and Administration of Medical Devices", "Measures for the Supervision and Administration of Medical Device Production"

Announcement of the second batch of national flight inspection ten companies to rectify within a time limit

(Summary description)In order to strengthen the supervision and management of medical devices and ensure the safety and effectiveness of medical devices, in accordance with the "Regulations on the Supervision and Administration of Medical Devices", "Measures for the Supervision and Administration of Medical Device Production"

  • Categories:Industry News
  • Author:
  • Origin:Ozida
  • Time of issue:2021-07-22
  • Views:0
Information

Announcement of the second batch of national flight inspection ten companies to rectify within a time limit

Notification of unannounced medical equipment inspections

(No. 2 of 2021)


In order to strengthen the supervision and management of medical devices and ensure the safety and effectiveness of medical devices, in accordance with the "Regulations on the Supervision and Administration of Medical Devices", "Measures for the Supervision and Administration of Medical Device Production", "Measures for Unannounced Inspections of Pharmaceutical and Medical Devices", "Medical Device Manufacturing Quality Management Regulations" and related appendices, and "Notice of the State Administration of Food and Drug Administration on Printing and Distributing 4 Guiding Principles including Guidelines for On-site Inspection of Medical Device Manufacturing Quality Management Regulations" (Food and Drug Administration [2015] No. 218) and other requirements, in accordance with the requirements of the State Drug Administration for Medical Devices in 2021 The inspection work was deployed. The inspection center organized unannounced inspections of medical device manufacturers from April to May 2021, and found that 9 companies including Beijing Quick Shuer Medical Technology Co., Ltd. had general items that did not comply with the "Medical Device Manufacturing Quality Management Standards" "And relevant appendix requirements; Zhuhai Aige Medical Technology Development Co., Ltd. (which has been discontinued before the inspection) has key items that do not meet the requirements of the "Medical Device Manufacturing Quality Management Standards" and relevant appendices. See the attached table for details.

In response to non-compliance issues found during the inspection, the relevant provinces, autonomous regions, and municipalities’ drug administrations are requested to urge enterprises to make rectifications as required, and require enterprises to assess product safety risks. If there are safety risks, they should be recalled in accordance with the "Medical Device Recall Management Measures" Related products. After the enterprise completes the rectification, the relevant provincial drug administrations shall promptly organize the confirmation of the rectification and submit the confirmation results to the Food and Drug Inspection Center of the State Drug Administration.

Attachment: Summary of the second batch of unannounced medical device inspections by the Verification Center in 2021.pdf.pdf

Announcement of the second batch of national flight inspection ten companies to rectify within a time limit

Announcement of the second batch of national flight inspection ten companies to rectify within a time limitAnnouncement of the second batch of national flight inspection ten companies to rectify within a time limitAnnouncement of the second batch of national flight inspection ten companies to rectify within a time limitAnnouncement of the second batch of national flight inspection ten companies to rectify within a time limitAnnouncement of the second batch of national flight inspection ten companies to rectify within a time limit

 

国家药监局核查中心

2021年7月20日

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