(Original title: The State Food and Drug Administration first organized the on-site inspection of production of overseas medical device manufacturers)
The State Food and Drug Administration has organized the first on-site inspection of production of overseas medical device manufacturers.
December 02, 2015
In order to further strengthen the supervision of the importation of imported medical devices after the listing, the State Food and Drug Administration recently organized an overseas inspection of the production quality management system for some overseas manufacturers of medical devices exported to China. On the one hand, the overseas inspection work is a sign that the General Administration of the People's Republic of China carries out international inspections according to the requirements of the regulations. On the other hand, it is to straighten out the working procedures for conducting international inspections, and to explore ways of working in the future. The overseas inspection is the first overseas inspection of medical device manufacturing enterprises organized by the State Food and Drug Administration after the newly revised "Quality Management Standards for Medical Device Production" and related appendices. It is the international medical device supervision work in China. An important step in the process.
The inspection work has received great attention from foreign medical device manufacturers. Through this inspection, it has greatly promoted the importance that foreign companies must pay attention to in compliance with China's medical device production quality management regulations and other relevant regulations, as well as the international inspection capabilities of medical device inspectors in China. The understanding of international medical device regulations and supervision by supervisors has improved the internationalization level of medical device supervision in China.