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MHLW 医薬機審発1225第1号・医薬監麻発1225第1号

医薬機審発1225第1号・医薬監麻発1225第1号

IVD product transition after partial-change approval or certification — joint notice of 25 December 2025
JapanMinistry of Health, Labour and WelfareRegistrationCurrentness under review
Document status

Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.

What this code is

医薬機審発1225第1号・医薬監麻発1225第1号 is the official MHLW identifier for “IVD product transition after partial-change approval or certification — joint notice of 25 December 2025”. 医薬機審発1225第1号・医薬監麻発1225第1号 is the official identifier MHLW uses for this instrument.

Instrument
医薬機審発1225第1号・医薬監麻発1225第1号
Full name
医薬機審発1225第1号・医薬監麻発1225第1号
Category
Registration
Source links
Source publication
Japanese
Linked source text; confirm the publisher, publication details and any later amendment or consolidated version.
Readable HTML
1 language version
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
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Effective
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

About this regulation

IVD product transition after partial-change approval or certification — joint notice of 25 December 2025

Complete 3-page joint notice, including its context for regenerative products, retained as one exact original. The IVD branch permits older-product shipment only for its stated technical fields and inventory/record conditions, and explicitly excludes Name, Intended Use and Method of Use. It applies to partial-change applications submitted on or after issue and rescinds the cited 2018 notice. It does not establish general sell-through of old-name labels or a general medical-device rule. Date is the printed notice date; present-day legal currentness remains unverified. Source images govern; native text is a qualified search layer. No whole-country completeness claim.

医薬機審発1225第1号・医薬監麻発1225第1号 is the official identifier MHLW uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.