Remaking of sunsetting instrument without significant amendments – Department of Health
On 4 September 2020, the Department of Health remade without significant amendments the Therapeutic Goods (Excluded Purposes) Specification 2010, which will sunset on 1 October 2020. The newly made Therapeutic Goods (Medical Devices - Excluded Purposes) Specification 2020 comes into effect on 1 October 2020 and will sunset on 1 October 2030.
The Specification, which is made under the Therapeutic Goods Act 1989, was first made in 2010 to set out exclusions from the permitted supply of specific categories of in-vitro diagnostic medical devices for self‑testing.
Consistent with the Government’s best practice regulation requirements for sunsetting instruments, the Department of Health has, after consultation with stakeholders, assessed the instrument as operating effectively and efficiently. Therefore, a Regulation Impact Statement is not required for remaking this instrument.