Section 41HD Application Form

Overview

About section 41HD

Section 41HD of the Therapeutic Goods Act 1989 (the Act) allows approval to be given for sponsors to supply and/or import medical devices:

• for a specified timeframe,
• when there is a disruption or shortage (or will be in the reasonably foreseeable future) of a device included in the Australian Register of Therapeutic Goods (ARTG), and/or
• it is in the interests of public health (for example, where the devices are critical for maintaining public health). 

Approval under section 41HD of the Act can only be granted if an applicant can demonstrate they meet criteria by providing evidence to support this.

Important

Medical devices approved for supply and/or import under section 41HD of the Act are subject to conditions of exemption imposed by the Secretary and are not considered to be included in the ARTG.

Additional permissions or restrictions may be imposed on the importation of certain kinds of medical devices (for example, devices containing tissues, tissue derivatives, cells or substances of animal or recombinant origin, medicines) through the following legislation:

• Biosecurity Act 2015
• Customs (Prohibited Imports) Regulations 1956
• The Poisons Standard (the Standard for the Uniform Scheduling of Medicines and Poisons)
• relevant state and territory legislation.