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IVD AIM dossier checklist

LISTA DE VERIFICAÇÃO DE UM PROCESSO DE PEDIDO DE AIM DE DISPOSITIVO MÉDICO DE DIAGNÓSTICO IN VITRO
MozambiqueAutoridade Nacional Reguladora de Medicamento, IPRegistrationCurrentness under review
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Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.

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LISTA DE VERIFICAÇÃO DE UM PROCESSO DE PEDIDO DE AIM DE DISPOSITIVO MÉDICO DE DIAGNÓSTICO IN VITRO is published by Autoridade Nacional Reguladora de Medicamento, IP. This document is identified by its title; no separate official document code is recorded.

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IVD AIM dossier checklist
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About this regulation

LISTA DE VERIFICAÇÃO DE UM PROCESSO DE PEDIDO DE AIM DE DISPOSITIVO MÉDICO DE DIAGNÓSTICO IN VITRO

IVD AIM dossier checklist covering analytical/clinical performance, specimens, traceability, stability, software, labels andQMS. Source-specific mandatory, conditional and optional markings and blankcells are retained. Finalnotes exempt Chapter4presentation for source-defined generic devices and state Chapters4and6submission is not mandatory for ClassBIVDs; no blanket underlying safety/evidence exemption is inferred. ManualAnnexIV parity, standalone version authority and current amendments remain open.

This document is identified by its title; no separate official document code is recorded. Always confirm the current consolidated text and transition provisions with the official source before filing.

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