ANARME, IP DocumentMedical Devices Essential Principles Checklist
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Medical Devices Essential Principles Checklist 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 Devices Essential Principles Checklist
Official-linked ANARME-branded English template covering device/IVD safety and performance, evidence, clinical evaluation, labels, implants and software. Preserve conflicting source clauses:13.1(3),13A.4 and13B require English;13.4(2) uses ClassI/ClassIIa/Class1IVD, unlike the local Portuguese/A–D framework. Exact template text is retained for consultation; this is not an established override of Decree19/2023 Article10 or proof of locally applicable classifications. Incorporation, current version and these conflicts 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.