First aid kits

Information for manufacturers and sponsors of first aid kits.

Last updated

19 December 2023

We regulate first aid kits. As they contain at least one medical device, they're system or procedure packs.

A first aid kit is a single medical device. As a result, they need to be on the Australian Register of Therapeutic Goods (ARTG).

Useful guidance

Supplying first aid kits that contain medical devices or medicines

30 September 2024

Guidance

Guidance for sponsors and manufacturers on regulatory responsibilities associated with first aid kits supplied using the special conformity assessment procedure.