Japan Clarifies Procedures for Medical Device Raw Material Changes

In January 2026, Japan’s Ministry of Health, Labour and Welfare (MHLW) issued a new notice clarifying the regulatory procedures for changes to raw materials used in medical devices. The notice replaces the prior guidance from 2013 to determine when a raw material change may be submitted as a minor change notification, instead of requiring partial change approval or a new approval.

The updated guidance applies to raw materials that directly or indirectly contact the human body. Certain low-risk materials, such as surface colorants or those with very brief contact duration, may be described by generic name in applications and may qualify for simplified change procedures. On the other hand, higher-risk categories are subject to stricter scrutiny. These include implant materials, long-term human contact components, biological-origin materials, biodegradable materials, and functional coatings.

The notice outlines the circumstances under which a raw material change would not qualify as a minor change. These include situations where the modification increases risk, introduces new safety concerns, affects therapeutic or diagnostic performance, or addresses serious post-market defects. In such cases, partial change approval or new approval may be required.

In addition, the guidance sets clearer criteria for determining whether a changed material has adequate prior use experience in Japan or in harmonized jurisdictions such as the US. Marketing Authorization Holders must conduct and document internal verification and submit a self-declaration statement when relying on the minor change pathway. The notice takes effect immediately.