The Protagonism of the Brazilian Health Regulatory System in the Evolution of Patient Safety in the Country: History, Dilemmas, and Current Challenges.

Objective: This article aims to identify and analyze the legal and regulatory frameworks with an interface with patient safety, considering the historical path of the patient safety policy in Brazil.

Methods: This is a historical review based on the relevant literature to the topic such as papers, legislation, and official documents with an interface with public health policies from 1988 to 2019. We also performed a documentary search to include data from the Brazilian Health Regulatory Agency (ANVISA) such as normative and nonnormative regulatory instruments.