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May 12, 2020 at 1:03 am #1000156tslaustraliaMember
- Total posts: 39
Importation of hand sanitisers and face masks
With many people making enquiries into the importation of hand sanitisers and face masks please refer below and links to the processors and protocols and the differences between TGA requirements and general everyday antibacterial products. It is clear from the links that the operative differences is that PRODUCTS that claim to be VIRUS grade require TGA approval.
“Face masks and gowns which are non-sterile and designed as safety or protective apparel for use in the home or for recreational or occupational use (for example, nursing) are excluded from regulation by the TGA under the Act.”
Face masks or gowns which are presented or claimed to be for therapeutic use, such as being labelled for surgical use, or to reduce or prevent the transmission of disease or micro-organisms such as bacteria or viruses, meet the definition of a medical device and are regulated by the TGA under the Act.
If these masks or gowns are supplied as non-sterile, they are likely to be regulated as low risk, class I medical devices.
That literally covers all of the masks being imported into Australia right now. Any mask that’s being declared as “not for therapeutic use” for importation purposes but then sold to consumers as protection against covid-19 infection would not be following this declaration guideline, would it? So can we assume that most of the masks being sold in Australia right now would have had to be declared and approved or were they incorrectly declared on purpose?
According to the “TGA issues warning about illegal advertising relating to COVID-19” page on TGA website, https://www.tga.gov.au/disinfectants-sterilants-and-sanitary-products
To read the Federal Register of Legislation, https://www.legislation.gov.au/Details/F2020N00033
To read NICNAS https://www.nicnas.gov.au/
Should you require any assistance in shipping and importation feel free to leave us a messageMay 14, 2020 at 11:52 am #1223178arrowwiseMember
- Total posts: 641
Some very good info TSL. There has already been huge unethical cash grabs from people bringing a lot of this non compliant rubbish in during the first wave. Hopefully these new requirements help to stamp out a lot the price gouging and dodgy operators.May 14, 2020 at 8:35 pm #1223179bb1Participant
arrowwise, post: 269729, member: 54026 wrote:Hopefully these new requirements help to stamp out a lot the price gouging and dodgy operators.
- Total posts: 4,472
Now that would be great wouldn’t it, but sadly they still seem to thrive no matter what guidelines are put in place, just take a look at the fuel companies, we had a 40 cent per litre price hike overnight, and the authorities just sat on their hands and did nothing.May 14, 2020 at 10:55 pm #1223180arrowwiseMember
- Total posts: 641
Fair point Bert. It’s all smoke and mirrors with trying to work out how they really price fuel. :confused:
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