Australia’s Therapeutic Goods Administration (TGA) proposed in July 2023 to develop a framework for audits for premarket device applications, but the Medical Technology Association of Australia (MTAA) registered several concerns about the proposal.
PERTH, Australia – Nearly three-fourths of medical device stakeholders supported introducing mandatory reporting of medical device-related adverse events by health care facilities in Australia, but many raised concerns about data duplication and integrity.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has undertaken a massive effort to reform its drug and device regulations, and as it pulls into the homestretch with those reforms, it is setting its sights to postmarketing efforts that include adverse event reporting, conformity assessments, patient-reported outcomes and a universal device identifier program.
PERTH, Australia – Australia’s budget theme for the 2021 to 2022 fiscal year is rebuilding the economy following COVID-19, and med-tech and biotech leaders were praising some of the new measures.
Australia's Therapeutic Goods Administration (TGA) recently posted a draft guidance for regulation of software as a medical device, but the Medical Technology Association of Australia expressed a preference for an international standard for risk classification.