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.

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).

RESULTS

Medical device applicability determinations in Japan relied extensively on product labeling, advertising claims, intended use, and soft-law instruments, including administrative notices and consultation records. Although this consultation-based approach provides flexibility in responding to emerging technologies such as artificial intelligence (AI)-based medical devices and Software as a Medical Device (SaMD), the legal reasoning and decision-making criteria were not always publicly available. The documentary comparison identified public guidance and regulatory information mechanisms in the United States and the European Union that offer examples for transparency policy design; it did not establish a jurisdiction-wide ranking of transparency or predictability.

CONCLUSION

Greater transparency in medical device applicability determinations could improve regulatory predictability while preserving the flexibility necessary for case-specific regulatory decisions. Publishing anonymized consultation cases, standardizing explanations of regulatory decisions, and expanding access to regulatory information may strengthen accountability, support responsible innovation, and reinforce public trust. These findings contribute to the literature on regulatory science, health policy, and evidence-informed regulatory governance for emerging medical technologies.