ANMAT DisposiciónDisposición 8799/2025
Simplified Establishment Authorization for Low-Risk Devices and IVDs
ArgentinaANMATRegistrationEffective November 28, 2025
What this code is
Disposición 8799/2025 is the official ANMAT identifier for “Simplified Establishment Authorization for Low-Risk Devices and IVDs”. Disposición 8799/2025 is the official identifier ANMAT uses for this instrument.
- Instrument
- Disposición
- Full name
- Disposición 8799/2025
- Category
- Registration
Source links
- Authority source
- Spanish
- Readable HTML
- 12 articles · 1 language version
Authority publication; confirm whether a later amendment or consolidated version applies.
Direct citations can link to an article, for example /data/regulations/argentina/disp-8799-2025.es.html#art-1.
Dates
- Published
- November 28, 2025
- Effective
- November 28, 2025
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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.
About this regulation
Simplified Establishment Authorization for Low-Risk Devices and IVDs
Simplified sworn-statement pathway for manufacturing or import authorization of Class I/II medical devices and IVD classes A/B.
Disposición 8799/2025 is the official identifier ANMAT uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.