The first China Drug Administration Scientific Congress in 2016 was held by China Society for Drug Regulation in Beijing. Sun Lei, deputy director of Supervising Department in China Food and Drug Administration, introduced the current supervision situations of medical devices and disclosed that the unannounced inspection team of medical devices has expanded up to 100 members.

Sun Lei said China Food and Drug Administration will continuously improve its ability of regulating medical devices and keep promoting inspection team building of medical devices. At present, the administration has recruited about 100 medical devices inspectors at national level. They will conduct unannounced inspection outside after 2 years training without intervals. In the aspect of improving regulation ability, information development and ability building in technology support institutions of medical devices supervision will be actively promoted. Experts, associations and social organizations will play effective roles in industry development.

Sun Lei also introduced basic information of 2015 national medical devices sampling, with a total of 72 varieties, 4,904 batches tested by the state and 12,373 batches tested at the province level. For inconformity with the standards, 4 measures will be taken: 1. Punish, put it in the regulation list and enhance inspection; 2. Ask manufacturers to improve quality management system, because unqualified products mean there must be something wrong with quality management system; 3. Form sample products quality assessment report; 4. Release quality announcement. This year has seen 6 quality announcements and supervision and selective testing of national medical devices.