How much fees should I prepare for the TGA certificate

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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
 

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C

celia4237

Re: How many fees should i prepare for the TGA certificate

BTW, i am really confused about the attached file that i get from the TGA's website.

What is the difference among the listed device, the included device and the registered device?
 
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