PMDA 医薬機審発0331第4号医薬機審発0331第4号 (31 March 2026)
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
医薬機審発0331第4号 (31 March 2026) is the official PMDA identifier for “Medical-device approval application instructions — 31 March 2026 amendment and reference text”. 医薬機審発0331第4号 (31 March 2026) is the official identifier PMDA uses for this instrument.
- Instrument
- 医薬機審発0331第4号
- Full name
- 医薬機審発0331第4号 (31 March 2026)
- Category
- Registration
- Source publication
- Japanese
- Readable HTML
- 1 language version
- 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.
Medical-device approval application instructions — 31 March 2026 amendment and reference text
The full19-page MHLW notice includes the amended/prior comparison and reference instructions. It expressly applies to medical-device approval applications from1May2026. Comparison columns must retain their separate meanings; this is not a universal brand or factory-change rule. Held bytes are preserved in full; this is not a current-law or whole-country completeness certification. The two-column/four-column comparative material is a source comparison, not a licence to combine prior and revised provisions.
医薬機審発0331第4号 (31 March 2026) is the official identifier PMDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.