Transparency in Medical Device Applicability Determinations in Japan: An Empirical Analysis of Administrative Consultation Records and Policy Implications

Background

Determining whether a product qualifies as a medical device is a fundamental step in medical device regulation because it defines the scope of regulatory requirements, including approval, advertising restrictions, and market access. In Japan, these determinations are based not only on statutory provisions but also on administrative notices, Q&A documents, and intergovernmental consultations. However, the transparency of the underlying decision-making process has received limited empirical investigation.