Australia Therapeutic Goods Act 1989 s41KA-41KC: Comply with recall and public notification requirements for devices that fail the essential principles, were not conformity assessed or breach prohibitions: recall distributed devices, inform the public or specified classes, publish manufacturing or distribution information and tell the Secretary who was supplied

What does s41KA-41KC require?

Where included devices are supplied but the Secretary is satisfied they do not meet the essential principles or have not had conformity assessment or comparable requirements applied, or where exempt or approved devices are supplied in those circumstances or a supply breaches a section 9K prohibition, the Secretary may impose written requirements on the sponsor or supplier to take specified steps to recall distributed devices, to inform the public or a specified class about the circumstances or specified information, to publish specified information about manufacture or distribution, and to notify the Secretary of the persons supplied, each in the specified manner and period. Devices already administered or applied in treatment cannot be recalled. Breach is an offence tiered by harm (up to 5 years or 4,000 penalty units) and a civil penalty (section 41KCA); requirements are published.