IMDRF
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has announced public consultations related to the document issued recently by the IMDRF. The International Medical Device Regulators Forum (IMDRF), a...
IMDRF
The International Medical Device Regulators Forum (IMDRF), a voluntary association of medical device regulating authorities collaborating on the improvement of the legislative framework has published a position paper describing the proposed approach to the post-market...
IMDRF
The International Medical Device Regulators Forum (IMDRF), a voluntary association of medical device regulating authorities collaborating on the improvement of the existing legal framework, has developed detailed proposals related to the application of quality...
IMDRF
In the course of continuous improvement of the regulatory framework for software as a medical device (SaMD), the International Medical Device Regulators Forum (IMDRF) has developed a new approach to SaMD risk categorization and corresponding consideration. The...
IMDRF
The Medical and Healthcare products Regulatory Agency (MHRA) of the UK has updated the information dedicated to tests and testing kits intended to detect the COVID-19. The information describes how the different types of COVID-19 tests operate and provides...
IMDRF
To ensure the sustainable development of innovative technologies, the International Medical Device Regulatory Forum (IMDRF) has developed a special framework for software with the intended medical purpose. Three guidance documents dedicated to terminology, risk-based...
