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
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
- Published
- November 28, 2025
- Effective
- November 28, 2025
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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.