Li Xintian: Unannounced Inspection and Post-supervision of Medical Devices

  • 2016-09-14



China Medical Devices Summit Forum (DeviceChina) was held beside the Dushu Lake on September 10, 2016, which is regarded as the most important high-end conference paying attention to the development of medical device industry. The summit continually focused on eco-development of medical devices industry, discussed development mode of global innovation and interpretation of capital market, set up branch of the summit and Road show of brilliant medical devices enterprise, made further efforts for communication and cooperation in order to promote healthy development of the industry.

The activity in the morning of September 11 was presided over Wang Jie, vice-director of Jiangsu Clinical Medical Research Institute & Jiangsu Provincial People’s Hospital. Li Tianxin, vice-director of medical devices department of Food and Drug Administration in Jiangsu Province, made a keynote speech of Unannounced Inspection and Post-supervision of Medical Devices as follows: As we all know, FDA has branch office in China with some sort of mutual check. In recent years, as many enterprises showed that visits of supervision departments from France and Brazil to China for assessment indicated more strictly international supervision and low efficiency of this method, attempt was made to effectively coordinate international regulations and laws. In my opinion, strictness is not only for China, but also for other countries as showed in FDA data. It is not good news that there are more and more examinations for these overseas countries with drastically increased warning examinations. So does European Union. In the past the supervision for IVD was very loose. But now it is not the case. Certification should be made, while it is not necessary in the past. Requirements of clinical evaluation have been enhanced.

DeviceChina actively builds industry healthy ecosystem, discusses frontier development trends, sets up professional communication platform and seeks for development solution. Since 2011, five successive summits have been successfully held. They attracted many nationally and internationally famous medical devices inventors, medical scientists, entrepreneurs, investors, and senior managers of transnational enterprises to be present at the summit and win good reputations in the industry.


Search