EFDA EFDAEFDA/GDL/084 Version No: 002
EFDA/GDL/084 Version No: 002 is the official EFDA identifier for “Guidelines for Medical Device Labeling (EFDA/GDL/084)”. EFDA/GDL/084 Version No: 002 is the official identifier EFDA uses for this instrument.
- Instrument
- EFDA
- Full name
- EFDA/GDL/084 Version No: 002
- Category
- Labeling
- Authority source
- English
- Readable HTML
- 22 articles · 1 language version
- Published
- 2026-06-01
- Effective
- 2026-06-30
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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 for Medical Device Labeling (EFDA/GDL/084)
The labelling guideline: what must appear on the label, the instructions for use and the packaging of a medical device placed on the Ethiopian market. Version 002, approved 01.06.2026, effective 30.06.2026; version 001 was first issued in 2021. Its contents and its body disagree by two from Scope onwards — the contents writes 3 Scope, 4 Objective, 5 labelling requirements while the body prints 1. Scope, 2. Objective, 3. labelling requirements — and the contents also lists "1.1. Exemptions from labelling requirements" out of place in the 6.5 area. The extract carries the body's numbering; the contents' numbering is the source's error and is reported, not corrected.
EFDA/GDL/084 Version No: 002 is the official identifier EFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.