European Technical File for registration in Australia

#1
Hello,

My company wants to register a CE marked product in Australia.

We have a technical file and a declaration of conformity written according to the European regulation (MDR 2017/745).

Can we use this technical file or do we need a technical file according to the Australian regulation?

Thank you in advance.
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
Is your product being used for COV-19?

We just submitted our DoC for MDD but we had an in country distributor assist us.

I suggest the easiest is an in country partner.
 
#3
Is your product being used for COV-19?

We just submitted our DoC for MDD but we had an in country distributor assist us.

I suggest the easiest is an in country partner.
Hello Ed,

Our product is not used for Covid. It is a kit composed of several devices used in the dental field.

We have a sponsor in Australia who will do the registration for us on the TGA website.

For the information to be provided, it is indicated that it is necessary to have a technical file. And we don't know if we can submit the European technical file or if we have to prepare a technical file according to the Australian regulations.
 

mboynton

Starting to get Involved
#4
Hi there,

In general, I do not think it is usually necessary to create a parallel technical file only for Australia. I would suggest incorporating a few Australia-specific elements in the same EU technical file, to be sure that the unique elements are covered for Australia:

1) Classification of your device according to the Australian rules
2) Conformity to the Australian Essential Principles (heavily borrowing from your evidence for conformity to the Essential Requirements in EU)
3) Link to the Australian Declaration of Conformity (see the templates on the Australian website)
4) Identification of the local sponsor

However, in your case, the situation could be somewhat different, based on the device being a kit, since procedure packs require an abbreviated set of documentation for EU, whereas it is treated as a single device for registration in the Australian ARTG (although since you note that the device is CE-marked, presumably you do not consider it as a procedure pack in EU?). If that could cause confusion, separate documents may be easier, but I am not aware of any regulatory restrictions on that - it would be up to your preference.

Based on the description of your product, I'd suggest reading over the TGA requirements on procedure packs, if you've not already taken a look:

[<https:// www .tga.gov.au/ update-medical-device-definitions-and-requirements-system-or-procedure-packs>]

and here:

[<https:// www .tga.gov.au/ sites/default/files/devices-argmd-01.pdf>]

Cheers,
 
#5
Hi there,

In general, I do not think it is usually necessary to create a parallel technical file only for Australia. I would suggest incorporating a few Australia-specific elements in the same EU technical file, to be sure that the unique elements are covered for Australia:

1) Classification of your device according to the Australian rules
2) Conformity to the Australian Essential Principles (heavily borrowing from your evidence for conformity to the Essential Requirements in EU)
3) Link to the Australian Declaration of Conformity (see the templates on the Australian website)
4) Identification of the local sponsor

However, in your case, the situation could be somewhat different, based on the device being a kit, since procedure packs require an abbreviated set of documentation for EU, whereas it is treated as a single device for registration in the Australian ARTG (although since you note that the device is CE-marked, presumably you do not consider it as a procedure pack in EU?). If that could cause confusion, separate documents may be easier, but I am not aware of any regulatory restrictions on that - it would be up to your preference.

Based on the description of your product, I'd suggest reading over the TGA requirements on procedure packs, if you've not already taken a look:

[<https:// www .tga.gov.au/ update-medical-device-definitions-and-requirements-system-or-procedure-packs>]

and here:

[<https:// www .tga.gov.au/ sites/default/files/devices-argmd-01.pdf>]

Cheers,
Hello,

Thank you very much for this information.

I used the term kit (my mistake), but the product is considered as a single device in Europe.

We don't want to incorporate the Australian specific elements (classification, Essential principles checklist...) in the EU technical file.
Can we just have them in addition to the EU technical file, or do we have to create a specific technical file for Australia?

Thank you for your help.
 

Mikilk

Involved In Discussions
#6
you are right about wanting to separate it as for EU you must keep a "clean" file with the MDD / MDR requirements for the review of the notified body / competent authority (depend on the class) review where requested.
you can keep additional records, but you will need to submit the file to TGA so you are recommended to keep a separate file to Australia in order to trace the submitted documents and versions.
as mentioned above, for some documents (such as the Declaration of Conformity) you will need to use the local template , the EU one is not fully fit
 
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