From 25 November 2021, new regulatory requirements apply to medical devices regulated as system or procedure packs and supplied using the special conformity assessment procedure. First aid kits are regulated by the Therapeutic Goods Administration (TGA) as medical devices that are system or procedure packs, as they contain a combination of two or more goods including at least one medical device, which are all packaged together for convenient use in an emergency and for rapid, initial treatment of injuries. This means that like other system or procedure packs, first aid kits are regulated as single medical devices in their own right and therefore must also be included in the Australian Register of Therapeutic Goods (ARTG). Accordingly, unlike 'kits' (as defined in section 7B of the Therapeutic Goods Act 1989) that do not contain any medical devices and, depending on their contents, are regulated as medicines, biologicals or other therapeutic goods, first aid kits always contain at least one medical device, and therefore are regulated as medical devices.

For inclusion in the ARTG, manufacturers of first aid kits (and other types of system or procedure packs) have two options to apply conformity assessment procedures to demonstrate that the medical device produced is safe and performs as intended. They may obtain market authorisation evidence, issued by an independent assessment body or regulator for the first aid kit; or use the special conformity assessment procedure if they meet the criteria related to 'medical devices used for a special purpose'. The revised regulations only apply to first aid kits that are supplied using the special conformity assessment procedure.

This guidance aims to assist sponsors and manufacturers of first aid kits supplied using the special conformity assessment procedure by explaining their obligations under the regulations and transitional arrangements for devices registered prior to 25 November 2021.

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