TGA - Application Fees - Exporting Medical Devices into Australia market

Hi mates,

My friend's company is going to export medical devices into Australia market.

As read from the TGA website, the requirements is almost similar to EU requirements. But I do have some query on the application fees and assessment audit fees will be charge during the process of product registration under the ARTG.

Anybody have the idea how much is the charges and is there any other charges involved?

Tiff

Can anyone help with this? My appreciation in advance.

This is what I get from google:

Fees & payments

How to Register a Medical Device in Australia

If you are still looking for assistance, there are some good consulting firms that have offices in Sydney, Australia. The first question is "has your product been cleared for home-country clearance/approval?" What country are you in, and have you met the regulatory requirements?

Registration is pretty straightforward. You do need either an office in Australia, or someone to represent you, register with TGA. Care to not hire a distributor, because you would have to divulge your confidential information and technical files. Rather, get an impartial third party professional firm. That way you can contract with more than one distributor. Also, New Zealand is considered separate now. Just google for some consultants with offices in Sydney, etc... g/l

MikeEmergo

Does anyone have any experiences they can share as to how long it took their device to be cleared in Australia? More specifically, a Class IIA medical device that has already obtained 510(k) clearance and has a CE mark? Thanks!

The paperwork takes about 2-5 weeks to process.

If you already have CE mark or an FDA 510k you just need to register your medical device with the TGA before they are marketed and assign a Sponsor (it is similar to a European Authorized Rep). I've done this for lots of clients through our office in Sydney, Australia. If you have further questions send me a message.

Good luck!