Submission: 2021 TGA therapeutic devices regulation

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