The reimbursement coverage decisions and pricing rules for medical devices in Taiwan.

Medical technology is undergoing rapid transformations, and the classifications of medical devices have also expanded greatly; therefore, it is necessary to develop appropriate reimbursement policies and pricing mechanisms in a timely manner. This paper aims to introduce the reimbursement coverage and pricing rules for medical devices in Taiwan. In addition, this paper identifies and evaluates available health technology assessments (HTA) and literature on published websites concerning medical device decision-making processes and pricing systems in South Korea and Japan, which are near Taiwan and have similar reimbursement coverage processes. Reimbursement policy and pricing mechanisms are constantly being revised in Taiwan, Japan, and South Korea. Recently, all three countries attempted to establish new reimbursement coverage decision-making and pricing rules, adopting a differentiated approach based on the level of evidence required for the appropriated reimbursement in terms of a feasible evaluation mechanism for providing patients with more effective medical devices. This article is expected to contribute to providing references to new reimbursement coverage decision-making and pricing rules.