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) is the designated technical representative responsible for ensuring GMP compliance and implementing the quality management system. The RT typically serves as the management representative for the QMS but does not relieve top management of overall accountability for the quality system. The RT must have direct and unrestricted access to top management to escalate critical compliance issues, and must report periodically to management on the status of the quality management system.
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The Responsável Técnico (RT) must be a qualified technical professional (typically with pharmaceutical, engineering, or relevant science qualifications) and must be formally appointed in writing. The RT's appointment and qualifications must be documented and submitted with the CBPF application or registration dossier.