Supervision and inspection of medical device supervision in Jiangxi Province

Recently, Jiangxi food and Drug Administration organized the business backbone of the administrative approval, inspection and law enforcement departments of medical devices and technical experts of technical review, certification inspection, inspection and testing institutions to conduct a comprehensive supervision on the registration management, production and operation supervision of medical devices in 11 districts and cities in Jiangxi Province in three groups The supervision personnel take the methods of consulting the supervision files, spot checking the enterprise site, organizing discussion, etc., and focus on the supervision of the registration and production and operation supervision of the first type of medical devices and the placement type of medical devices At the same time of business work supervision, the supervision group, through going deep into the grass-roots level and the front line of enterprises, carried out various forms of investigation and research, widely listened to the opinions of grass-roots regulatory departments and enterprises, and focused on solving the prominent problems that the masses reflected strongly in the supervision of medical devices and industrial development In this inspection, 830 class I medical device registration and approval files, 156 production and operation enterprise regulatory files and 53 production and operation enterprises were randomly inspected, and 18 outstanding problems in the registration management and production and operation supervision of medical devices in cities were sorted out, and local regulatory authorities were instructed to issue 24 notice of ordering correction, cancellation according to law or enterprises' initiative application note 50 class I medical device registration certificates have been sold, 6 cases of various violations have been filed and investigated; 12 symposiums attended by supervisors and enterprise representatives have been held on site, focusing on 10 opinions and suggestions of grass-roots regulatory departments and enterprises.