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Medical-device AIM dossier checklist

LISTA DE VERIFICAÇÃO DE UM PROCESSO DE PEDIDO DE AIM DE DISPOSITIVO MÉDICO
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 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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Medical-device AIM dossier checklist
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About this regulation

LISTA DE VERIFICAÇÃO DE UM PROCESSO DE PEDIDO DE AIM DE DISPOSITIVO MÉDICO

General MD AIM dossier checklist:administrative, product description, nonclinical, clinical, labelling andQMS chapters. Mandatory markings, blank cells and endnotes are preserved together. Finalnotes exempt Chapter4 presentation for source-defined generic devices and state Chapters4and6submission is not mandatory for ClassB; these do not establish exemption from every underlying safety/evidence obligation. ManualAnnexIII row parity, standalone version authority and current amendments remain unresolved.

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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