Compliance
ANVISA (Brazil)
Agência Nacional de Vigilância Sanitária
TL;DR
Brazil's national health-surveillance agency — regulator for pharmaceuticals, medical devices, food, cosmetics and sanitisers under Law 9.782/1999.
ANVISA operates the Brazilian GMP regime (RDC 658/2022 for medicines, RDC 665/2022 for devices) and is an MDSAP regulator. Imported devices require a Brazilian Registration Holder; imported medicines require a local Marketing Authorisation Holder. ANVISA accepts MDSAP for QMS audits but conducts its own product registration review.
Labelling, leaflet and packaging requirements are uniquely strict and must be in Brazilian Portuguese.
Regulatory anchors
- ANVISA RDC 658/2022 (pharma GMP)
- ANVISA RDC 665/2022 (device QMS)
- Lei 9.782/1999
Industries that live with this
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