Medical device regulations evolve for Australian innovators with European ambitions
Medical device regulation is undergoing significant change as regulators across major jurisdictions grapple with the rapid growth of software and artificial intelligence (AI) in healthcare.
Speaking with Australian Health Journal at the Medical Technology Association of Australia’s RegConnect Summit 2026 in Sydney in September, Gabrielle Cesvet, Head of Public Affairs at Scarlet, said manufacturers need greater clarity and sufficient lead time as new regulatory frameworks emerge.