Hey guys,
Just an email from this company I purchased masks from in the past. TGA approved, fast response from customer service when I emailed them. Ordered last from them about a month ago for my mum, good quality, thought you would like to know.
Haha no worries
ARTG registration means nothing. It just means someone has taken the time to fill in a form. It doesn't mean that it has been tested, or that the TGA approves of the results. It doesn't mean that it's quality is any good or that the TGA approves of it's quality.
I don't know why people even bother saying they have ARTG registration, except for marketing.
And registration is not equal to approval.
If Seller is using Surgical or Medical words, They have to get TGA approval as per latest guidelines.
If Surgical or medical words are not mentioned on the Box itself or on seller's website, they are okay to sell without TGA approval.
There are hefty fines if Seller ignores the above guidelines.
My 2 cents.
Source.
Because the TGA guidelines are that if it meets the broad definition of a medical device, then it can be registered on the ARTG. Everything else like tests, etc only need to be provided during post marketing review.
https://www.tga.gov.au/post-market-review-face-masks-overvie…
There are already hundreds of withdrawn ARTG surgical mask entries.
https://www.tga.gov.au/post-market-review-face-masks-cancell…
Hundreds. So you can register your mask on the ARTG, make bank, and then when the TGA asks for proof, you can just withdraw your entry.
…thanks for letting us know jimmy-member-since-15-mins-ago!
…also say hi to ya mum for me too