MHLW 薬生機審発0731第5号薬生機審発0731第5号
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
薬生機審発0731第5号 is the official MHLW identifier for “Medical-device minor-change notification procedures — MHLW notice of 31 July 2017”. 薬生機審発0731第5号 is the official identifier MHLW uses for this instrument.
- Instrument
- 薬生機審発0731第5号
- Full name
- 薬生機審発0731第5号
- 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.
Medical-device minor-change notification procedures — MHLW notice of 31 July 2017
Complete 14-page official notice and attached examples, dated 31 July 2017. It clarifies partial-change approval versus minor-change notification for medical devices. Page 2 states that the 23 October 2008 notification’s Annex 1 examples continue to qualify for minor-change notification and that its Annex 2 is not changed by this notification. No blanket rescission is inferred. Date is the printed notice date, not a proven portal publication or commencement date. This is medical-device guidance; industry-association addressees do not extend its substantive scope to IVD. Source images govern; native text is a qualified and potentially incomplete search layer. Legal currentness is unverified.
薬生機審発0731第5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.