MHLW Document事務連絡（令和7年12月25日・製品切替えQ&A）
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
IVD product transition after partial-change approval or certification — Q&A of 25 December 2025 is published by Ministry of Health, Labour and Welfare. This document is identified by its title; no separate official document code is recorded.
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IVD product transition after partial-change approval or certification — Q&A of 25 December 2025
Complete 5-page official administrative communication and attached five-question Q&A, including regenerative-product examples retained in original context. It addresses IFU revisions, successive changes before stock exhaustion, partial implementation, master-file changes and application wording/removal. It rescinds the cited 2018 Q&A. Application to IVD remains subject to the companion notice’s limited field scope; no general old-name-label sell-through or medical-device rule is inferred. Date is the printed communication date; present-day legal currentness remains unverified. Source images govern; native text is a qualified search layer. No whole-country completeness claim.
This document is identified by its title; no separate official document code is recorded. Always confirm the current consolidated text and transition provisions with the official source before filing.