关键词: font-size:medium, ">医疗器械；医疗器械唯一标识（UDI）；零部件直接标记（DPM）；二维条码

Abstract: The unique device identifier(UDI) is the unique identification code of medical devices， which is the basis of accurately collecting medical devices′ whole life cycle data， and is also the hot spot in the field of medical device supervision. Direct part mark（DPM）is a permanent bar code marking technology. Compared with other common bar code labels， DPM has the characteristics of adapting to harsh environment， anti-wear， anti-pollution and long service life etc.It can meet the requirements of data collection， quality supervision and traceability management in the whole life cycle of medical devices. This technology is an important means to realize UDI permanent marking and is the development trend of medical device bar code marking. This study intends to systematically analyze the choice of data carrier and marking method for the application of DPM 2D code marking on medical devices based on the advancement of UDI implementation in China. The experience was summarized and suggestions for improvement of direct marking of medical devices were put forward， in order to provide a preliminary research basis for the standardization improvement of 2D code integrated with DPM technology， and provide technical support and reference for the accurate implementation and promotion of UDI in China.

Key words: Medical devices, Unique device identifier, Direct part mark, 2D Code