Brazil Requires Certification For Wireless Device Registration
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The tests are being moved to class II, special controls, after the agency determined that would be enough to ensure device safety and efficacy.
The user fee package was among several health-related bills that the subcommittee took up on Wednesday.
The move removes all regulatory roadblocks to Medtronic’s $1.1bn acquisition of Intersect ENT, which was announced in August 2021.