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PPE | Regulatory Compliance

Is your business manufacturing PPE or medical scrubs? There are some legal considerations!

COVID-19 has created huge demand for the supply of therapeutic goods like masks, hospital gowns and scrubs. Businesses from other industries are pivoting to start supplying these products to meet demand and support the fight against COVID-19. The big question is to what extent must these products comply with therapeutic goods regulations. Here’s a cheat sheet.

The TGA vibe | If you say the product has a ‘therapeutic use’ then it will be regulated as a therapeutic good. That means getting it included on the Australian Register of Therapeutic Goods (ARTG), following labelling rules and a bunch of other compliance obligations. If you don’t claim that the product has a therapeutic use, or if it’s covered by an exemption, then you have a shorter path to market and fewer compliance obligations. E.g. there’s an exemption for masks, gloves, gowns and eye wear going into the government’s COVID-19 emergency stockpile.

Therapeutic Use | The definition is broad, but for PPE the main considerations are whether you say the product is sterile, whether it prevents the transmission of bacteria or other micro-organisms, prevents the spread of disease, kills viruses, stuff like that.

Gowns | Most gowns have a therapeutic use, as their purpose is generally to prevent the transmission of micro-organisms or infection between the health provider and patient in a treatment setting. That means they come under TGA regulation.

Masks | Masks intended for hospital use or which make therapeutic claims like sterility, preventing transmission of pathogens, germs, disease, viruses etc. are therapeutic goods. Non-sterile protective or safety equipment used in the home or for occupational or recreational use is not treated as therapeutic goods and avoids TGA regulation.

Promoting your product | For all products, you must comply with the Australian Consumer Law. This includes complying with guarantees that products are of acceptable quality, fit for purpose and match any description. You must also avoid misleading advertising. And if you are selling medical devices, you must also comply with the Therapeutic Goods Advertising Code. It creates extra rules for what you can, can’t and must say in all advertising.

Scrubs | Most scrubs and apparel are not subject to TGA regulation as they do not claim any therapeutic use. The exceptions are those which claim a therapeutic use, such as being sterile or acting as a barrier to prevent cross-contamination or the transmission of infection.

Don’t be a criminal. Also don’t freak out | Given the increased demand, there is plenty of opportunity for supplying therapeutic goods right now. The industry is highly regulated, and criminal offences apply for non-compliance. But don’t freak out. The rules are all manageable if you get across them before jumping in.

WORDS | Marque Lawyers

For more specific support please reach out to Hannah and Danielle directly.

Hannah Marshall | Partner | hannahm@marquelawyers.com.au | +612 8216 3088
Danielle Kroon | Lawyer | daniellek@marquelawyers.com.au | +61 2 8216 3099

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