AMA Submission to the TGA on proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods

This submission addresses proposed options for improving current regulation of exempt medical devices and Other Therapeutic Goods, under the three categories of changes detailed in the consultation paper.

These are simple changes responding to the noted increase in the use of exemptions by smaller medical device manufacturers in particular, in the context of a changed medical device regulatory framework. The AMA agrees the proposed changes are an appropriate response to address this trend and promote consistent regulation and oversight of exemptions.

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