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Submission: 2021 TGA therapeutic devices regulation

Osteopathy Australia's submission to the TGA on proposed refinements to the regulation of personalised medical devices focused on plagiocephaly helmets and foot orthoses.

The Therapeutic Goods Administration (TGA) proposed a number of refinements to the regulation of therapeutic goods. Osteopathy Australia's recommendations included: that the TGA should require plagiocephaly helmets be subject to inclusion on the ARTG as a medium risk medical device for redirecting the growth of a baby, infant or young child’s skull; and that the TGA should exclude clinical foot orthoses from ARTG registration and ARTG registration exemption applications.

See: TGA therapeutic devices regulation: Osteopathy Australia submission 2021

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