According to a report by the Emergo Group, regulators in the United States, Brazil, Canada and Australia have signed an agreement for the development of a unified medical device audit program. Information from the unified audit program would be used by all four government regulatory groups.
The new agreement will form a bond between the United States Food and Drug Administration (FDA), the Brazilian ANVISA, Health Canada and the Australian Therapeutic Goods Administration (TGA). All four watchdog agencies plan to improve audit efficiency with the establishment of the Medical Device Single Audit Program (MDSAP). Once MDSAP is established, a device that meets the regulatory requirements in one of the member countries will be qualified for approval in all the member countries. In addition to reducing research and auditing costs, the new move will help medical device companies bring devices to new markets with minimal financial hurdles.
In addition to the above goals, the MDSAP will also promote mutual acceptance and work-sharing arrangement among participating countries. This will allow different countries to pool their regulatory resources together.
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