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AO 2018-0002

Administrative Order No. 2018-0002 - Medical Devices Regulation (Full Text PDF)
PhilippinesFood and Drug AdministrationGeneralEffective January 2018
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What this code is

AO 2018-0002 is the official FDA identifier for “Administrative Order No. 2018-0002 - Medical Devices Regulation (Full Text PDF)”. AO 2018-0002 is the official identifier FDA uses for this instrument.

Instrument
AO
Full name
AO 2018-0002
Category
General
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Authority source
English
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Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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0 articles · 1 language version
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Dates
Published
26 January 2018
Effective
January 2018
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English full text0 articles · English — official FDA scan (embedded OCR layer)Read HTML →
About this regulation

Administrative Order No. 2018-0002 - Medical Devices Regulation (Full Text PDF)

Administrative Order No. 2018-0002 (26 January 2018): guidelines governing the issuance of an authorization for a medical device based on the ASEAN Harmonized Technical Requirements — Sections I-XV (rationale, scope, definitions, general/specific/procedural guidelines, fees, phased implementation, sanctions, appeal, confidentiality, separability, repealing, effectivity) plus Annexes A-K (legal and technical requirements, application forms, and an example submission). The official FDA file is a scan whose embedded OCR layer fragments into one-word lines; the corpus reassembles it through strictly-sequenced heading promotion, so occasional OCR concatenations (e.g. "SAN CTIONS") are preserved as-published.

AO 2018-0002 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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