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Management Responsibility

RDC 752/2022 requires top management of medical device manufacturers to demonstrate commitment to the quality management system. Key management responsibility requirements include:

  • Establishing and communicating the quality policy to all employees;
  • Defining the organizational structure and responsibilities;
  • Appointing a management representative for the QMS;
  • Conducting management reviews at planned intervals;
  • Ensuring adequate resources (personnel, infrastructure, work environment) are provided;
  • Establishing quality objectives that are measurable and aligned with the quality policy; and
  • Ensuring customer requirements are understood and met.

The Responsável Técnico (RT) often serves as the management representative for the QMS, but top management remains accountable.

Official sources

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