Acuerdo 0258-ARSA-2025
Acuerdo 0258-ARSA-2025 is the official ARSA identifier for “Reglamento especial para la implementación del mecanismo de confianza regulatoria (Reliance)”. Acuerdo 0258-ARSA-2025 is the official identifier ARSA uses for this instrument.
- Instrument
- Acuerdo
- Full name
- Acuerdo 0258-ARSA-2025
- Category
- Registration
- Source publication
- Spanish
- Readable HTML
- 1 language version
- Published
- 2026-01-26
- Effective
- —
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Reglamento especial para la implementación del mecanismo de confianza regulatoria (Reliance)
Complete seven-page original agreement signed 8 December 2025 and published 26 January 2026 in La Gaceta 37053. Article 2 expressly includes medical devices alongside medicines. Sets reliance principles, reference-authority criteria, national safeguards and an annual official authority list. Commences thirty days after publication; implementation instruments and the current annual list must also be checked. Physical page 8 is Gazette subscription advertising and is excluded.
Acuerdo 0258-ARSA-2025 is the official identifier ARSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.