Identifying Policy Issues Surrounding Medical Device Globalization The Japanese Market: A case study of issues and their resolution potential

Healthcare globalization has multiple definitions: Medical tourism, telemedicine, worldwide clinical trials, brain drain, and regulatory harmonization. Each of these plays a role in the goal of consistent country-by-country access to the latest pharmaceuticals, medical devices, and medical care. Medical devices, from tongue depressors to MRI machines, are used to aid in making therapeutic decisions, diagnosis, treatment and drug monitoring for various medical conditions. Regulatory oversight of the initial approval through to post-marketing surveillance is unique to different regions of the world resulting in redundancy of costs, clinical investment, and long delays. For approximately 25 years, global efforts via the global harmonization task force been developed to synchronize medical device regulatory frameworks unique to each country. Through literature reviews as well as industry interviews, this paper presents present the components and challenges of global medical device harmonization, looking at progress, challenges, and future opportunities, specifically using the Japanese market as a case study. Of needed change is regulatory harmonization, global clinical cooperation, and industry programs to assist manufacturers in new market entry. Presentation: 25 minute