EDA EDREX:EDREX: GL.CAMD.002
EDREX: GL.CAMD.002 is the official EDA identifier for “Regulatory Guideline for Registering Imported and Local Medical Devices with International Quality Certificates”. EDREX: GL.CAMD.002 is the official identifier EDA uses for this instrument.
- Instrument
- EDREX:
- Full name
- EDREX: GL.CAMD.002
- Category
- Registration
- Authority source
- English
- Readable HTML
- 0 articles · 1 language version
- Published
- September 2025
- Effective
- September 2025
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Regulatory Guideline for Registering Imported and Local Medical Devices with International Quality Certificates
EDREX: GL.CAMD.002 version 02/2025 (issued 09/2025; 56 pages): registration procedures for imported and local medical devices holding international quality certificates (CE, FDA, reference-country certificates) — separate procedure tracks for sterile devices (receiving, evaluating, and completing registration files on the electronic platform) and non-sterile devices (Class IIa/IIb/III imported and local, system and bundling registration, 18-month importation windows for temporary acceptance numbers), specialized scientific committees including stability and biocompatibility evaluation, re-registration, general requirements, and Appendices 1-6 (document lists for imported, local, and F-Toll manufacturing submissions). URL updated to the current v02/2025 file on the official CA-of-Medical-Device guidelines index; the previously recorded media URL is a stale hash that now returns the Arabic homepage.
EDREX: GL.CAMD.002 is the official identifier EDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.