Australia's Therapeutic Goods Administration has proposed the use of overseas marketing approval of medical devices to support inclusion in the Australian Register of Therapeutic Goods or the sharing of such work with comparable overseas regulators to advance parallel submissions. Under the proposal, which is open for comments until June 30, the Australian regulator would only evaluate International Medical Device Regulators Forum members but would also use application-by-application assessment for work-sharing agreements.
Australia proposal would allow device approvals from some overseas regulators
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