The goal is to further minimize duplication. The already existing MRA, for example, contributes on average to a cost saving of 380,000 US$ per inspection and additionally frees up important resources for the authorities.
This cooperative work is in line with the ongoing efforts of the International Medical Device Regulators Forum (IMDRF), which in 2018 developed a guide to help regulators develop their UDI systems in a globally harmonised way.
Australia, Brazil, Canada, Japan and the USA are already participating in the MDSAP. Canada announced its participation in the MDSAP in early January. MDSAP enables recognized audit firms to conduct a single audit of a medical device manufacturer that meets the requirements of multiple regulatory agencies for Quality Management Systems (QMS) and Good Manufacturing Practices (GMP).
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