Oct 16, 2020
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...
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Oct 13, 2020
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...
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Sep 28, 2020
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...
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Sep 25, 2020
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...
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Jun 4, 2020
Canada
The Health Products and Food Branch of Health Canada, the Canadian regulating authority in the sphere of medical devices, issued a notice on the expansion of the medical device Regulatory Enrolment Process (REP) pilot program. Regulatory Enrolment Process: Regulatory...
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