Language
Chinese
English
News Information News Information

News Information

/
/
/
Our province launches the second-class medical device verification work

Our province launches the second-class medical device verification work

(Summary description)Recently, the Provincial Food and Drug Administration issued the "Working Procedures for the Inspection of the Quality Management System for the Registration of Second Class Medical Devices in Henan Province (Interim)" in accordance with the "Administrative Measures for Medical Device Registration" and "In Vitro Diagnostic Reagents Registration Management Measures". The inspection work of the second-class medical device quality management system in our province is guaranteed by the system.

Our province launches the second-class medical device verification work

(Summary description)Recently, the Provincial Food and Drug Administration issued the "Working Procedures for the Inspection of the Quality Management System for the Registration of Second Class Medical Devices in Henan Province (Interim)" in accordance with the "Administrative Measures for Medical Device Registration" and "In Vitro Diagnostic Reagents Registration Management Measures". The inspection work of the second-class medical device quality management system in our province is guaranteed by the system.

Information

Recently, the Provincial Food and Drug Administration issued the "Working Procedures for the Inspection of the Quality Management System for the Registration of Second Class Medical Devices in Henan Province (Interim)" in accordance with the "Administrative Measures for Medical Device Registration" and "In Vitro Diagnostic Reagents Registration Management Measures". The inspection work of the second-class medical device quality management system in our province is guaranteed by the system.

It is reported that the highlight of this inspection lies in standardizing on-site inspections. The inspection team formulates on-site inspection plans before on-site inspections. The contents include the basic situation of the company, inspection varieties, inspection purposes, inspection basis, on-site inspection time, schedule, inspection items, and inspection team members And division of labor. The inspection team shall be composed of more than two inspectors, and the inspection team leader shall be responsible for the on-site inspection, and the team leader shall be responsible for organizing and convening relevant meetings, collecting on-site inspection materials, and verifying on-site inspection conclusions.

Scan the QR code to read on your phone

Related Information
Related Products
返回顶部

Jiangsu Kanghua Medical Equipment Co., Ltd.

Focus on the production and sales of disposable medical devices and large infusion medicine packages.

Quick Link

Contact Us

Jiangsu Kanghua Medical Equipment Co., Ltd.  苏ICP备14001887号-1   Powered by:www.300.cn  IPv6 is supported6