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ANRS/MINSA Resolución

Resolución Administrativa 0004/2024

Contratos de fabricación, maquila, terceros y acuerdos de calidad para dispositivos médicos y sus modificaciones
NicaraguaAutoridad Nacional de Regulación Sanitaria, Ministerio de SaludGMP/QMS
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What this code is

Resolución Administrativa 0004/2024 is the official ANRS/MINSA identifier for “Contratos de fabricación, maquila, terceros y acuerdos de calidad para dispositivos médicos y sus modificaciones”. Resolución Administrativa 0004/2024 is the official identifier ANRS/MINSA uses for this instrument.

Instrument
Resolución
Full name
Resolución Administrativa 0004/2024
Category
GMP/QMS
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Spanish
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About this regulation

Contratos de fabricación, maquila, terceros y acuerdos de calidad para dispositivos médicos y sus modificaciones

Complete 22-page resolution and Annexes I and II establishing approval requirements for manufacturing, contract manufacture and medical-device quality agreements and subsequent modifications. Device implementation starts one month after signature; no exact effective date is inferred from an unclear signature date.

Resolución Administrativa 0004/2024 is the official identifier ANRS/MINSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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