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FDA Philippines LTO

LTO Charter XVI

License to Operate (LTO) Guidelines for Medical Device Establishments
PhilippinesFood and Drug AdministrationRegistrationEffective 2023
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What this code is

LTO Charter XVI is the official FDA identifier for “License to Operate (LTO) Guidelines for Medical Device Establishments”. LTO Charter XVI is the official identifier FDA uses for this instrument.

Instrument
LTO
Full name
LTO Charter XVI
Category
Registration
Source links
Authority source
English
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Dates
Published
August 2023
Effective
2023
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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 text0 articles · English — official FDA citizen’s charter sheetRead HTML →
About this regulation

License to Operate (LTO) Guidelines for Medical Device Establishments

Citizen’s-charter sheet (section XVI of the FDA charter compilation) for the initial License to Operate for medical device traders, distributors, wholesalers, and importers via the FDA eServices portal: a 5-item checklist (application per AO 2020-0017, proof of business registration, site master file, and LTO fees scaled to capitalization) and the client-steps process table totalling 14 working days.

LTO Charter XVI is the official identifier FDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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