Medical devices
Transparency in Medical Device Applicability Determinations in Japan: An Empirical Analysis of Administrative Consultation Records and Policy Implications
By Nakata T.
Abstract
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.
Methods
This qualitative single-case study analyzed 10 administrative records covering July 7 to November 11, 2025, and combined legal analysis, thematic analysis of administrative consultation records and written responses obtained through freedom of information requests, and international comparison with regulatory frameworks in the United States, the European Union, the World Health Organization (WHO), and the International Medical Device Regulators Forum (IMDRF).