PURPOSE: To share the findings from the MedtecHTA, which is the large, three-year EU-funded research project about the HTA for the assessment of medical devices, and to make recommendations for researchers and health policy makers to solve the challenges in the HTA of medical devices DESCRIPTION: Currently, the specific features of medical devices and major challenges in HTA of medical devices are not widely known among researchers and policy makers in Asia-Pacific region. This session will start with an introduction of the specific features of medical devices and major challenges in HTA of medical devices. Considerations will be given to the specific characteristics of medical devices which include user learning curve, incremental innovation, significant price change over time and organizational impact as well as key challenges of the HTA of medical devices which include the relative lack of RCTs and the inherent uncertainty about clinical and cost-effectiveness at the time of product launch. This session will make a comprehensive recommendations for developing methods for HTA of medical devices.