C
celia4237
I am a manufacturer of blood pressure monitor in China, and now i want to enter the ARTG, my boss want me to make a budget for it.
I think the blood pressure monitor belongs to class 2a, and we have already get a MDD certificate from TUV, so i think the fee we have to pay is the item: Inclusion in the ARTG (d) Class 2a medical device, 760$.(PLease refer to the attachment for the fees requirement from TGA) And i think there is little possibility for us to make a Level 1 application, is it right? Or maybe there will be a annual fee?
How much fees should i preapre in total?
Thanks a lot
I think the blood pressure monitor belongs to class 2a, and we have already get a MDD certificate from TUV, so i think the fee we have to pay is the item: Inclusion in the ARTG (d) Class 2a medical device, 760$.(PLease refer to the attachment for the fees requirement from TGA) And i think there is little possibility for us to make a Level 1 application, is it right? Or maybe there will be a annual fee?
How much fees should i preapre in total?
Thanks a lot