Antimicrobial coatings that are incorporated in manufacture or applied to surfaces (physical barrier) to protect itself are generally considered sanitation/environmental control/environmental detoxification equipment and fall under item 12 of Schedule 1 to the Therapeutic Goods (Excluded Goods) Determination 2018. Therefore not regulated by TGA.
It would be considered an industrial chemical and regulated by AICIS (Australian Industrial Chemicals Introduction Scheme). Requires checking that the ingredients are on the AICS inventory and label compliance for hazardous chemicals.
The words hospital grade disinfectant, hard surface disinfectant or disinfection etc, should not be used to describe this product, limited only to antimicrobial coating.
The TGA consider antimicrobial coatings that are in the same form as disinfectants, i.e. liquids, sprays, wipes, sponges and aerosols and applied to a surface like these types of disinfectants, are disinfectants and therefore regulated by TGA. Following are the regulatory pathways for these types of products:
As manufacturers develop “smarter” disinfectants and sanitisers the regulators are being forced to play catch-up. Getting these new products to market can be frustrating but the rewards are there for those who persist.