PMDA 医薬機審発0507第1号医薬機審発0507第1号 (7 May 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0507第1号 (7 May 2026) is the official PMDA identifier for “IVD approval application instructions — 7 May 2026 corrected expression”. 医薬機審発0507第1号 (7 May 2026) is the official identifier PMDA uses for this instrument.
- Instrument
- 医薬機審発0507第1号
- Full name
- 医薬機審発0507第1号 (7 May 2026)
- Category
- Registration
- Source publication
- Japanese
- Readable HTML
- 1 language version
- Published
- —
- Effective
- —
Open a language version
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.
IVD approval application instructions — 7 May 2026 corrected expression
Complete38-page MHLW corrected expression, with correction notice, comparison material and reference instructions. Ordinary-device and IVD change categories remain distinct; prior and revised columns are not interchangeable. 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0507第1号 (7 May 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.