Rwanda FDA DFARDFAR/HMDAR/TRG/002 Rev_2
DFAR/HMDAR/TRG/002 Rev_2 is the official Rwanda FDA identifier for “Regulations Governing the Registration of Medical Devices including In Vitro Diagnostics (DFAR/HMDAR/TRG/002 Rev_2)”. DFAR/HMDAR/TRG/002 Rev_2 is the official identifier Rwanda FDA uses for this instrument.
- Instrument
- DFAR
- Full name
- DFAR/HMDAR/TRG/002 Rev_2
- Category
- Registration
- Authority source
- English
- Readable HTML
- 40 articles · 1 language version
- Published
- —
- Effective
- 2020-04-20
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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.
Regulations Governing the Registration of Medical Devices including In Vitro Diagnostics (DFAR/HMDAR/TRG/002 Rev_2)
The technical regulations that carry Rwanda's device registration obligation: 40 articles across four chapters, from classification and the application dossier through assessment, the certificate, validity, variations, renewal, suspension and cancellation to labelling and the restriction on selling unregistered devices. Two articles matter beyond registration and are why this is the market's lead instrument: Article 16 ("Reliance") and Article 31 (label and labelling of medical devices or IVDs). The copy states "Date for coming into effect 20th April 2020" and its revision history records revision 0 on 20/04/2020 (first issue), revision 1 on 08/06/2021 and revision 2 on 22/08/2022, so the row's effective date is the date the document states and the revisions are recorded here. Chapter headings in the extract follow the document's own casing, including its "Chapter Ii" — the source's typography, not repaired.
DFAR/HMDAR/TRG/002 Rev_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.