TGA Calls for Preapproval of Mainstream Medical Device Advertisements

Medical devicemakers who advertise their products in Australia’s mainstream and specified media would be required to get their advertisements preapproved under a Therapeutic Goods Administration (TGA) proposal to extend a system currently limited to nonprescription drugs. The recommendation to add devices to the preapproval system follows an uptick in the number of consumer complaints concerning device advertisements, and a comparable number of complaints related to advertisements for over-the-counter (OTC) drugs, according to a TGA report, “Advertising regulatory framework — options for reform.”
International Medical Device Regulatory Monitor