Essential Requirements & Performance (ABNT/ISO Standards)
RDC 751/2022 Annex II defines the Essential Requirements (Requisitos Essenciais) all medical devices must meet. Categories: general requirements (safe and performing as intended), design and construction, labelling and IFU, active devices (electrical safety, EMC, software), devices with measurement function, implantable devices, and radiation-emitting devices.
Compliance is demonstrated by reference to harmonised ABNT standards (creating presumption of conformity), international standards (ISO, IEC, ASTM), or test data. The dossier must include a completed Essential Requirements Checklist mapping each requirement to evidence.
Verify all information against official ANVISA sources before making regulatory decisions.
The Essential Requirements Checklist (also called the Conformity Assessment Report) must be completed for each device and included in the dossier. A template can be obtained from ANVISA or developed based on RDC 751/2022 Annex II. The checklist must show the requirement number, requirement text, applicable ABNT/ISO standards or test data, and the location of supporting evidence in the technical dossier.
Non-Harmonised Standards Pathway: When a harmonised ABNT standard does not exist for your device category, compliance must be demonstrated through: (1) reference to relevant ISO, IEC, or ASTM international standards (with documentary evidence of alignment with RDC 751/2022 requirements), (2) manufacturer testing and validation data, or (3) a combination of published scientific literature and proprietary test data. In all cases, the Essential Requirements Checklist must clearly map the requirement to the evidence source and justify why this approach demonstrates compliance. ANVISA reviewers may request additional information to confirm that non-harmonised pathways provide equivalent safety assurance.