Module 19 2021

01/06/2021

GHTF steering committee GHTF study groups

GHTF Study group

Title

SG1 SG2 SG3 SG4 SG5

Pre-market evaluation

Post-market surveillance/vigilance

Quality systems

Auditing

Clinical safety/performance

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GHTF Regulatory model

The key subsystems of the GHTF Regulatory Model are: ● risk-based pre-market controls; ● a system for post-market vigilance and surveillance; ● a quality management system and risk management process encompassing the life- cycle; and ● a regulatory audit process to periodically assess conformity, ● harmonized definitions; ● registration of manufacturers and listing of medical devices; ● applying clinical evaluation and clinical evidence during the life-cycle; ● labeling; ● Field Safety Notices; and ● communications to users of medical devices.

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