TGA Disinfectant Wipes Registration

MINHAAZD

Registered
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

Involved In Discussions
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
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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