Our province launches the second-class medical device verification work
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.
Jul 31,2015
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.
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