ABNT Standards Recognised by ANVISA
ABNT Standards Recognised by ANVISA — ANVISA medical device regulation in Brazil.
How to Read ANVISA RDCs & Portarias
How to Read ANVISA RDCs & Portarias — ANVISA medical device regulation in Brazil.
MERCOSUL Harmonised Resolutions
MERCOSUL Harmonised Resolutions — ANVISA medical device regulation in Brazil.
Normative Instructions & Portarias
Normative Instructions & Portarias — ANVISA medical device regulation in Brazil.
Primary Legislation
The foundational legislation governing medical device regulation in Brazil — key Leis and their role in the ANVISA framework.
RDC 10/2015 — Clinical Investigations
RDC 10/2015 — Clinical Investigations — ANVISA medical device regulation in Brazil.
RDC 36/2015 — IVD Registration & Classification
RDC 36/2015 — IVD Registration & Classification — ANVISA medical device regulation in Brazil.
RDC 751/2022 — Core Medical Device Registration Regulation
RDC 751/2022 — Core Medical Device Registration Regulation — ANVISA medical device regulation in Brazil.
RDC 752/2022 — GMP (CBPF)
RDC 752/2022 — GMP (CBPF) — ANVISA medical device regulation in Brazil.
RDC 753/2022 — Adverse Event Reporting & Recalls
RDC 753/2022 — Adverse Event Reporting & Recalls — ANVISA medical device regulation in Brazil.
RDC 754/2022 — Labelling Requirements
RDC 754/2022 — Labelling Requirements — ANVISA medical device regulation in Brazil.
RDC 755/2022 — Establishment Authorisation (AFE)
RDC 755/2022 — Establishment Authorisation (AFE) — ANVISA medical device regulation in Brazil.
Recent Amendments & Revogações (Repeals)
Recent Amendments & Revogações (Repeals) — ANVISA medical device regulation in Brazil.