Variations in the Medical Device Authorization and Reimbursement Landscape: A Case Study of 2 Cardiovascular Devices Across 4 Countries.

Abstract

The authorization process and coverage/reimbursement mechanisms for medical devices play critical roles in device adoption and usage. However, international variation in these processes remains poorly characterized, especially with regard to data transparency and the effects of reimbursement on usage. This study examined publicly available databases, governmental agency recommendations and policies, and press releases from the United States, Canada, the United Kingdom, and the Netherlands to com