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Australian Registration of Non-CE Marked Medical Device

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sde99

#1
We manufacture a class IIa medical device and are looking to get the device registered in Australia. I understand the process is simplified if the device has a CE mark, I am wondering what are the additional requirements if the device is not yet CE marked?
Many thanks for any help.
 
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QAengineer13

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#2
We manufacture a class IIa medical device and are looking to get the device registered in Australia. I understand the process is simplified if the device has a CE mark, I am wondering what are the additional requirements if the device is not yet CE marked?
Many thanks for any help.
Hi Sde99,

To obtain access to the Australian market, medical device and IVD manufacturers will need to include their product in the Australian Register of Therapeutic Goods (ARTG), regulated by the Therapeutic Goods Administration (TGA).

Step 1
Determine classification using Schedule 2 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002.

Step 2
If you have no local presence in Australia, appoint an Australian Sponsor. The Sponsor facilitates your device registration, acts as the liaison between the manufacturer and the TGA, and the Sponsor’s name must appear on your device and labeling.

Step 3
Have current Technical File or Design Dossier (Class III) and Declaration of Conformity ready for submission.

Step 4
For all devices except Class I Non-sterile, non-measuring, Sponsor submits Manufacturer’s Evidence (CE Marking certificate) in eBS system for TGA's review and acceptance.

Step 5
Class III devices will undergo a Level 2 Application Audit. The design dossier is reviewed by the TGA.

Step 6
For all classes, the Australian Sponsor submits Medical Device Application online in eBS system. The Application should include Intended Purpose statement, classification and GMDN code. Pay application fee.

Step 7
The TGA will approve or reject your application. If approved by the TGA, an Australian Register of Therapeutic Goods (ARTG) listing number will be issued (ARTG Certificate of Inclusion) and your listing will be included in teh ARTG database on the TGA website.

Step 8
You may now begin marketing your device in Australia. Registrations do not expire as long as you do not make changes to the device that would invalidate the ARTG listing, a current CE Marketing certificate (if applicale) is on file with the TGA, and the annual ARTG listing fee is paid.

Hope this helps!
 

Ronen E

Problem Solver
Staff member
Moderator
#3
We manufacture a class IIa medical device and are looking to get the device registered in Australia. I understand the process is simplified if the device has a CE mark, I am wondering what are the additional requirements if the device is not yet CE marked?
Many thanks for any help.
Hi,

In a nutshell, the process is quite similar to CE marking. Instead of engaging with a NB and registering with a Competent Authority in the EU, you have similar dealings with the Australian TGA (performing both functions of NB and CA). You can, alternatively, elect to be audited by an EU NB (instead of by the TGA) but given the currrent backlog most NBs have I guess that's not an attractive option.

Please note that the Australian Sponser will hold the legal right to import the sponsored devices into Australia. This is non-exclusive, a device / manufacturer can have more than one Australian Sponsor, but each such sponsor will need their own application (and resulting ARTG entry). This is also true of devices cleared through the CE mark route.

All the details are here; however, the ARGMD hasn't been reissued in a long time and there are some updates (though the process in general hasn't changed). If you need closer assistance please let me know.

Cheers,
Ronen.
 
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