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- PublicationsSummary and outcomes: review of the regulation of certain self-testing in vitro diagnostic medical devices (IVDs) in AustraliaSummary and outcomes of recent consultation on IVD self-tests.
- PublicationsThis statement guides decision making to help address concerns with joint replacement prostheses.
- PublicationsPrepare for a technical file review as part of your application to include an in vitro medical device in the Australian Register of Therapeutic Goods.
- PublicationsGuidance to assist manufacturers in choosing appropriate standards and to set out the TGA's expectations for performance testing