Rwanda FDA DHTDHT/GDL/024 Version 2
DHT/GDL/024 Version 2 is the official Rwanda FDA identifier for “Guidelines for Registration of Medical Devices (DHT/GDL/024 Version 2)”. DHT/GDL/024 Version 2 is the official identifier Rwanda FDA uses for this instrument.
- Instrument
- DHT
- Full name
- DHT/GDL/024 Version 2
- Category
- Registration
- Authority source
- English
- Readable HTML
- 80 articles · 1 language version
- Published
- —
- Effective
- —
Open a language version
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 for Registration of Medical Devices (DHT/GDL/024 Version 2)
The registration guideline the technical regulations are worked through: the application route, the classification statement, the QMS expectation, the review committee and the timelines, followed by the dossier itself laid out as the submission's own chapters — administrative information (1.01–1.15), submission context (2.01–2.11), non-clinical evidence (3.01–3.11), clinical evidence (4.01–4.07), labelling (5.01–5.10), the quality management system evidence (6.01–6.17) — and five appendices. It is dated NOVEMBER, 2025 on its cover, and its own "Effective date of this revision" field is left blank in the published copy (literally "...."), so no effective date is recorded: the blank is the source's and is not filled with the cover month. The publisher's file name says December 2025 against the cover's November; the cover is what the row follows. Version 2 is the current revision of a guideline the Authority first issued under the same document number.
DHT/GDL/024 Version 2 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.