EDA EDREX:EDREX: GL.CAP.Care.040
EDREX: GL.CAP.Care.040 is the official EDA identifier for “The Egyptian Guideline for Medical Device Vigilance System”. EDREX: GL.CAP.Care.040 is the official identifier EDA uses for this instrument.
- Instrument
- EDREX:
- Full name
- EDREX: GL.CAP.Care.040
- Category
- Vigilance
- Authority source
- English
- Readable HTML
- 0 articles · 1 language version
- Published
- November 2025
- Effective
- November 2025
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The Egyptian Guideline for Medical Device Vigilance System
EDREX: GL.CAP.Care.040 version 1/2025 (issued November 2025; issued by the Central Administration of Pharmaceutical Care, General Administration for Pharmaceutical Vigilance): the medical device vigilance system operated with the Medical Devices Safety Unit (MDSU) — stakeholders' roles (users, manufacturers, MDSU), manufacturer pre-market obligations for registration/re-registration, post-market surveillance (PMSR and PSUR reporting, trend reporting), adverse-event incident reporting with timeframes and IMDRF coding, field safety corrective action (FSCA) and field safety notice (FSN) notification, and the reporting form annexes (user feedback, UIR, declarations, MIR, PSR, trend report, FSCA/FSN forms; annexes 2-13 extract as form tables without standalone headings and fold into one block). Supersedes the 2013 edition listed in its references. Not on the current CA-of-Medical-Device guidelines index, but the official URL still serves the PDF.
EDREX: GL.CAP.Care.040 is the official identifier EDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.