Abstract:Medical devices are directly related to human health. Normative naming is very important for accurate identification and correct use of medical devices, and it is also an important basic work of medical device supervision. The United States Food and Drug Administration (FDA) identifies all levels of names in the classified database by category, allows enterprises to use commodity names to release personalized needs, encourages enterprises to adopt third-party terminology system to deal with international trade, and gradually forms an official and commercial complementary naming system. This paper summarized the status quo of medical device naming in the United States, combed the application of the level, type and name of medical device naming in the United States, briefly described the progress of medical device naming in China, compared the similarities and differences of medical device naming between China and American, and analysed the potential reasons, so as to provide reference for the construction of medical device naming system in China.
杨婉娟 李静莉▲. 美国医疗器械命名进展及启示[J]. 中国医药导报, 2019, 16(3): 49-52.
YANG Wanjuan LI Jingli▲. Progress and enlightenment of naming medical devices in the United States. 中国医药导报, 2019, 16(3): 49-52.