Risk Management (ISO 14971)

ANVISA adopts ISO 14971:2019 (Brazilian: ABNT NBR ISO 14971) as the standard for risk management.

The complete risk management file for Class III/IV includes: risk management plan, hazard identification, risk estimation and evaluation, risk control measures, residual risk evaluation, benefit-risk analysis, risk management report, and post-market data integration.

Class	Risk management requirement
Class I	Summary
Class II	Summary with key risk controls
Class III	Full ISO 14971 file
Class IV	Full file with extended benefit-risk analysis

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.