Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 2) (Cth)

Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 2)¹

Select Legislative Instrument 2008 No. 270

I, QUENTIN BRYCE, Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 12 December 2008

QUENTIN BRYCE

Governor‑General

By Her Excellency’s Command

JAN MCLUCAS

Parliamentary Secretary to the Minister for Health and Ageing

Name of Regulations

These Regulations are the Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 2).

Commencement

These Regulations commence on the day after they are registered.

Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

Schedule 1 amends the Therapeutic Goods (Medical Devices) Regulations 2002.

Schedule 1 Amendment

(regulation 3)

[1] Schedule 4, Part 2, table, after item 2.8

insert

2.9

Medical device that is a system or procedure pack under section 41BF of the Act that:

(a) is imported, supplied or manufactured by or on behalf of the Commonwealth; and

(b) is certified by the Secretary to be emergency supplies for stockpiling for use in the event of a public health emergency.

(a) The device must be imported, supplied or manufactured on or before 31 December 2010.

(b) The importation, supply or manufacture of the device must be approved in writing by the Secretary.

(d) Records in relation to the importation, supply or manufacture of the device must be kept in accordance with the directions of the Secretary.

(e) The disposal of any unused device must be in accordance with the directions of the Secretary.

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See