TGA Disinfectant Wipes Registration

#1
Hi Guys,

We have a product that is a hand wipe (disinfectant) (Non Medical Device) currently being sold in auustralia.

I’m trying to put together timescales and costs for us replacing the formulation in this product i.e. would there need re-registration as we will have new data.

does anyone know the requirements for this and the registration pathway also.

Thanks, Much Apprecuiated
 

medwise

Quite Involved in Discussions
#2
confused - your subject title says TGA disinfectant wipes and your message says non-medical device. If your product is a therapeutic goods then TGA will assess formulation change.
 

QAengineer13

Quite Involved in Discussions
#3
Hi Guys,

We have a product that is a hand wipe (disinfectant) (Non Medical Device) currently being sold in auustralia.

I’m trying to put together timescales and costs for us replacing the formulation in this product i.e. would there need re-registration as we will have new data.

does anyone know the requirements for this and the registration pathway also.

Thanks, Much Apprecuiated
Please see this hyperlink https://www.tga.gov.au/disinfectants-sterilants

Regulations: https://www.tga.gov.au/regulation-disinfectants-and-sterilants
 
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