Abstract:Post-marketing research on medicines and medical devices is an important aspect of product lifecycle management. Based on literature research and expert consultation, this article proposes a conceptual system for post-marketing research of pharmaceutical and medical devices, which includes a 3WHO framework of what is post-marketing research(What), why should post-marketing research(Why) be conducted, who should conduct post-marketing research(Who), how to conduct post-marketing research(How), and the objective of post-marketing research (Objective).