CMDR Charter
CMDR Charter is the official FDA identifier for “Center for Medical Device Regulation (CMDR) Registration Guidelines”. CMDR Charter is the official identifier FDA uses for this instrument.
- Instrument
- CMDR
- Full name
- CMDR Charter
- Category
- Registration
- Authority source
- English
- Readable HTML
- 0 articles · 1 language version
- Published
- July 2023
- Effective
- 2023
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Center for Medical Device Regulation (CMDR) Registration Guidelines
Citizen’s-charter sheet for initial Certificate of Medical Device Registration (CMDR) applications: fee Php 7,500.00, 5-year validity, a 12-item checklist of requirements (notarized application form, letter of authorization, proof of business registration, ISO 13485 certificate, and CESP/other technical documents per AO 2018-0002 Annexes), and the client-steps process table totalling 80 working days.
CMDR Charter is the official identifier FDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.