DOC-GDL-009
DOC-GDL-009 is the official LMHRA identifier for “Guidelines on Post-Authorization Safety Studies”. DOC-GDL-009 is the official identifier LMHRA uses for this instrument.
- Instrument
- DOC-GDL-009
- Full name
- DOC-GDL-009
- Category
- Vigilance
- Source publication
- English
- Readable HTML
- 1 language version
- Published
- —
- Effective
- 2026-04-16
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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.
Guidelines on Post-Authorization Safety Studies
Complete official 20-page LMHRA guideline issued 13 April 2026 and implemented 16 April. Definitions and assessment provisions explicitly include medical devices; contains submissions, review, amendments, reporting and annexed checklist. The cover says Version 003 while its document-control field says Version 01; both are retained as printed rather than resolved by assumption.
DOC-GDL-009 is the official identifier LMHRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.