TGA Guidelines on Australian & EU Medical Device Regulatory Requirements Differences

TGA Guidelines on “Differences between the Australian and European Union medical device regulatory requirements” has been released as draft. This guidance document has been created to assist Australian manufacturers who export medical devices to the EU or who intend to export to the EU, Australian sponsors who wish to import CE marked medical devices into the Australian market & overseas manufacturers who wish to manufacture for both the European and Australian markets.

NOTE: Dead Link Removed.

Re: Differences between Australian & EU Medical device regulatory requirements

Hellow! The guideline is what I would like to obtain.
But I cannot open it, so could you attached the link again?
Thanks,
Mickey

Re: Differences between Australian & EU Medical device regulatory requirements

Mickey1102 said:

Hellow! The guideline is what I would like to obtain.
But I cannot open it, so could you attached the link again?
Thanks,
Mickey

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Welcome to the Cove

You could get the differences in this document - Australian Regulatory Guidelines for Medical Devices - Part 1 and then click section 8 for the specific differences between Australia and EU requirements.

Re: Differences between Australian & EU Medical device regulatory requirements

Dear Mr.Ajit Basrur:

I would like to thank you for your kind reply.
That's very helpful of you.

Now, as for the new regulation DRAFT of Medical Devices in India, I believe that three or four DRAFTs (like "schedule-M3" and "revised Drug and Cosmetics act.", and so on) remain stalled in Indian Congress.

Could you advise me about the expected date of its enactment and which DRAFT will be approved in the Indian Congress, if you have any information?

Regards,
Mickey

Re: TGA Guidelines on Australian & EU Medical Device Regulatory Requirements Differen

Sorry Mickey. I do not know when

Re: TGA Guidelines on Australian & EU Medical Device Regulatory Requirements Differen

Dear Mr.Ajit Basrur:
Thank you very much for your quick response.
regards,
Mickey