ISSUE: The regulations of medical devices across the Asia-Pacific region are quite different, which makes it more difficult to initiate an international harmonization of HTA. The panel will debate a possibility of reflecting the success or failure stories in Europe and potential challenges in adjusting them to fit Asian environment. Following to the introduction by a moderator, each panelist will speak for 10 minutes. Then, the panel will have a 15-minute panel discussion about potential international cooperation, and 15 minutes or longer of Q&A from the audience. OVERVIEW: ISPOR HTA Roundtable held in last September discussed about HTA of medical devices and diagnostics in Asia-Pacific. The delegates agreed that the effectiveness of a medical device depends upon many variables, such as training and skills of end users, patient selection, and quality of care setting, etc. Also most medical devices can't be evaluated using RCTs because of ethical and practical issues in the choice of comparator. These factors make it more challenging to generate clinical evidence traditionally requested by the regulatory process, although the ISPOR-ISPE Joint Special Task Force on Real-World Evidence in Health Care Decision-Making has shed lights in this direction and the European Commission is being paving the way to harmonize clinical assessment of medical devices.