EDA EDREX:EDREX: GL.CAMD.009
EDREX: GL.CAMD.009 is the official EDA identifier for “Regulatory Guideline for Registration of Locally Manufactured Medical Devices Without International Quality Certificates”. EDREX: GL.CAMD.009 is the official identifier EDA uses for this instrument.
- Instrument
- EDREX:
- Full name
- EDREX: GL.CAMD.009
- Category
- Registration
- Authority source
- English
- Readable HTML
- 0 articles · 1 language version
- Published
- 1 September 2025
- Effective
- September 2025
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Regulatory Guideline for Registration of Locally Manufactured Medical Devices Without International Quality Certificates
EDREX: GL.CAMD.009 version 02/2025 (issued 01/09/2025): the registration pathway for locally manufactured medical devices from factories holding ISO 13485:2016 certification without a CE certificate — EU-MDD Annex IX classification, factory technical requirements (manufacturing-site conditions, room layout, sterilization, controlled and clean rooms, HVAC/air handling), pre-registration procedures (technical operation license, pilot-batch sampling and analysis, 120-working-day corrective-measures window), registration procedures, and Annexes I-III (document list, factory technical requirements, vigilance obligations). URL updated to the current v02/2025 file on the official guidelines index; the previously recorded media URL is a stale hash that now returns the Arabic homepage.
EDREX: GL.CAMD.009 is the official identifier EDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.