Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EEC)

H

Hello - 2006

Hi,
I would like to seek for expertise advice on the process of importing medical device (class IIa as per MDD 93/42/EEC classification) to Australia. We have got our CE mark recently, do they recognize CE mark? What other requirements should we comply in order to get the clearance to import out products to the country.
Thanks in advance. :thanx:
 

Al Rosen

Leader
Super Moderator
Hello said:
Hi,
I would like to seek for expertise advice on the process of importing medical device (class IIa as per MDD 93/42/EEC classification) to Australia. We have got our CE mark recently, do they recognize CE mark? What other requirements should we comply in order to get the clearance to import out products to the country.
Thanks in advance. :thanx:
Youi can find that discussed in the thread: Exporting medical devices to Australia - Regulatory system for medical devices

Also, I've attached various documents from the Australian TGA. You will find the answer you are looking for in the document titled: Guidelines on Standard of Overseas Manufacturers.
 

Attachments

  • Australia TGA.zip
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Last edited:

renenatasha

Involved In Discussions
Re: Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EE

Thanks, Al.. That's very helpful. However, the docs are more than a decade old :) Have those docs been revised or can we still use it as reference? If not, do you mind sharing the link?

Thanks a zillion :)
 

Ronen E

Problem Solver
Moderator
Re: Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EE

Thanks, Al.. That's very helpful. However, the docs are more than a decade old :) Have those docs been revised or can we still use it as reference? If not, do you mind sharing the link?

Thanks a zillion :)

Hi,

The Australian regulations have somewhat changed over the years...

From the TGA's website:

Overseas manufacturers not manufacturing medical devices described above, and who hold current EC certification issued by an EU Notified Body under the EU Medical Devices Directive 93/42/EEC (MDD) or the EU Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) are allowed, under certain conditions, to use EC certificates to support an application for inclusion onto the ARTG. A copy of the required certification must be submitted to the TGA prior to the lodgement of the device application for inclusion to the ARTG.

The ARGMD is your best friend for Australian registration.
 
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