Australia Therapeutic Goods Act 1989
Chapter 4 Parts 4-5 and 4-6: including medical devices in the Register, conditions, suspension and cancellation – Australia Therapeutic Goods Act 1989

Australia Therapeutic Goods Act 1989 s41FO-41FP-41MN: Comply with conditions the Secretary imposes on an ARTG device entry (manufacture, custody, purpose, supply, disposal, records including post-supply tracking, extra essential principle matters) and with prescribed and ministerial conditions, because any breach is an offence and civil penalty

What does s41FO-41FP-41MN require?

When including a kind of device, and later by written notice, the Secretary may impose, vary or remove conditions about manufacture; custody, intended purpose, supply, disposal or destruction; record keeping including tracking and location of devices after supply; matters in or beyond the essential principles; or any other matter the Secretary considers appropriate. New or varied conditions take effect immediately where the notice says that is needed to prevent an imminent risk of death or serious illness or injury, and otherwise not less than 20 working days after notice unless the sponsor agrees earlier. A sponsor whose act or omission breaches any condition of inclusion commits an offence (up to 5 years or 4,000 penalty units where harm results or is likely, 12 months or 1,000 penalty units, and a 100 penalty unit strict liability tier) and contravenes a civil penalty provision (section 41MNA); breaching the conditions of exemptions, approvals and authorities is covered in the same way (sections 41MN(9) to (9B), 41MNB and 41MNC).

Maintained by Gerard Blokdyk

Other controls in Chapter 4 Parts 4-5 and 4-6: including medical devices in the Register, conditions, suspension and cancellation – Australia Therapeutic Goods Act 1989

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.