Pure Global AI
EFDA EFDA

EFDA/GDL/098 Version No: 002

Guideline for Medical Device Post-Approval Change Notification (EFDA/GDL/098)
EthiopiaEthiopian Food and Drug AuthorityRegistrationEffective 2026-06-30
Official source linked
What this code is

EFDA/GDL/098 Version No: 002 is the official EFDA identifier for “Guideline for Medical Device Post-Approval Change Notification (EFDA/GDL/098)”. EFDA/GDL/098 Version No: 002 is the official identifier EFDA uses for this instrument.

Instrument
EFDA
Full name
EFDA/GDL/098 Version No: 002
Category
Registration
Source links
Authority source
English
Open the issuing-authority text
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
8 articles · 1 language version
Read the full text →
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
2026-06-21
Effective
2026-06-30
Readable full text

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.

English full text8 articles · English — EFDA/GDL/098 Version 002 official textRead HTML →
About this regulation

Guideline for Medical Device Post-Approval Change Notification (EFDA/GDL/098)

The variations guideline: which changes to a registered device must be notified to the Authority after approval, how the notification is made, and what the Authority does with it. Version 002, approved 21.06.2026, effective 30.06.2026; version 001 was first issued in 2021. The shortest of the eight guideline expressions (its contents lists eight sections and it carries the notification form as its last section), which is why its extract holds nine blocks.

EFDA/GDL/098 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.

Verified