TGA Information on Hand Sanitiser and Masks

Due to an increased number of enquiries from the trading community, the Therapeutic Goods Administrator (TGA) has recently released a range of guidance on COVID-19 specific issues, including masks and hand sanitiser.

Hand Sanitiser

The TGA web page Hand sanitisers and COVID-19 outlines the requirements for the three classes of hand sanitiser:

• General consumer goods (for personal or domestic use, without specific claims, etc)
• Hand sanitisers regulated by TGA (claiming to kill specific organisms, and/or for use in clinics and hospitals)
• Specific formulations excluded from TGA regulation for the duration of the COVID-19 pandemic (limited ingredients and strict labelling requirements)

Additional information has also been published clarifying advertising claims, including in the context of the exemption www.tga.gov.au/covid-19-update-advertising-claims-and-hand-sanitisers

Masks

A range of advice on the regulation and use of personal protective equipment (PPE), including masks, has been provided:

Regulation of Personal Protective Equipment and COVID-19 –www.tga.gov.au/behind-news/regulation-personal-protective-equipment-and-covid-19 outlining that most PPE is exempt from TGA regulation, but where PPE is intended for therapeutic use it needs to be
included in the Australian Register of Therapeutic Goods (ARTG) at the appropriate classification prior to import, supply, export or advertising. This page includes information on the manufacturer and supply of PPE in Australia, applicable standards, and a description of various sorts of face masks as well as gowns, goggles and visors.

In terms of regulatory compliance, except where exemptions have been put in place, normal regulatory requirements apply. While TGA has not relaxed normal regulatory requirements which apply, any applications received for COVID-19 relevant products are being prioritised.
This includes GMP requirements for medicines (such as regulated hand sanitisers), and conformity assessment requirements for medical devices.

Comparable overseas regulators

Comparable overseas regulatory arrangements for medical devices (noting this does not apply for hand sanitisers, which are regulated under the medicines framework). The TGA has long accepted certification from European notified bodies as evidence of compliance with the conformity assessment procedures, in addition to the conformity assessment certificates issued by the TGA. Since October 2018, comparable overseas regulators and assessment bodies include the US FDA, Health Canada and Japanese regulators.

The details of what evidence (certificates, documents etc) from comparable overseas regulators can be used is outlined in guidance on the TGA website: www.tga.gov.au/publication/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds. Table 2 in particular outlines what documents must be included with the application for inclusion for each device classification. It should be noted that this is evidence to support the application for inclusion on the ARTG, and is still subject to TGA assessment and decision.

For many applications, this will be completed within 20 working days (and as mentioned above TGA are prioritising COVID-19 related applications) but these applications may be selected for audit and further information requested (audit is mandatory for a range of high-risk devices).