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EFDA/GDL/090 Version No: 001

Medical Device Vigilance Guideline (EFDA/GDL/090)
EthiopiaEthiopian Food and Drug AuthorityVigilanceEffective 2026-06-30
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EFDA/GDL/090 Version No: 001 is the official EFDA identifier for “Medical Device Vigilance Guideline (EFDA/GDL/090)”. EFDA/GDL/090 Version No: 001 is the official identifier EFDA uses for this instrument.

Instrument
EFDA
Full name
EFDA/GDL/090 Version No: 001
Category
Vigilance
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54 articles · 1 language version
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Dates
Published
2026-06-15
Effective
2026-06-30
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English full text54 articles · English — EFDA/GDL/090 official text (cover and history say Version 001)Read HTML →
About this regulation

Medical Device Vigilance Guideline (EFDA/GDL/090)

The post-market vigilance guideline: adverse-event and incident reporting, the reporting routes and timelines, and the surveillance the Authority carries out — the guideline that the Directive's vigilance obligations are worked through. Version 001, approved 15.06.2026, effective 30.06.2026, and the only version: this guideline was first issued in 2026, unlike its siblings. Its cover and Document History say version 001 while the running footer of the copy says "Version No: 002"; the extract carries the document as published and the record follows the cover and the history table (Version No: 001 in the code field), with the footer discrepancy stated here rather than silently preferring one.

EFDA/GDL/090 Version No: 001 is the official identifier EFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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