Abstract: Pediatric medical devices are being paid more and more attentions in many countries because of its importance. In this paper, the standards and regulation status of pediatric medical devices in China and USA are summarized. Several documents related to pediatric medical devices issued by FDA are introduced, including guidance for industry and FDA staff, premarket assessment of pediatric medical devices and barriers to the availability of medical devices intended for the treatment or diagnosis of diseases and conditions that affect children. Some suggestions are provided to develop the satndards and regulations for pediatric medical device in China.

Key words: pediatric medical devices, guidance, standard