Rwanda FDA ODGODG/RAHC/GDL/001 Rev_.3
ODG/RAHC/GDL/001 Rev_.3 is the official Rwanda FDA identifier for “Guidelines on Reliance for Regulatory Decision-Making (ODG/RAHC/GDL/001 Rev_.3)”. ODG/RAHC/GDL/001 Rev_.3 is the official identifier Rwanda FDA uses for this instrument.
- Instrument
- ODG
- Full name
- ODG/RAHC/GDL/001 Rev_.3
- Category
- General
- Authority source
- English
- Readable HTML
- 15 articles · 1 language version
- Published
- —
- Effective
- 2024-02-23
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Each version has stable article 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 Reliance for Regulatory Decision-Making (ODG/RAHC/GDL/001 Rev_.3)
Rwanda FDA's reliance guideline: the principles it applies when it recognises another regulator's work, the reliance pathways it offers, the areas where it will rely (marketing authorization, GMP inspections, vigilance, clinical trials, quality-control testing, market surveillance and control) and the procedure and documentation for a reliance application. Revision 3, effective 23/02/2024 on the document's own statement, first issued 14/06/2021. It is a medicines-and-devices instrument rather than a device-only one, and it is the reliance text a device applicant reaches for in this market.
ODG/RAHC/GDL/001 Rev_.3 is the official identifier Rwanda FDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.