Any Idea why Manufacturer with CE device does not seek Australian approval?

E

endlesslovehv

#1
*
Do u know the reason why a manufacturer that has a C.E. mark on its device may not pursue Australian approval?
:thanx:
 
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G

George Weiss

#2
Re: Australia

With the larger markets to chase, (China, Europe, and USA), and fees to pay for market entry, some how Australia was overlooked?
Maybe the product was like selling Ice to an Eskimo, or a kangaroo to Australia? No offence intended......................
.
What is the company and produce you refer to?
 
E

endlesslovehv

#3
Re: Australia

I just looking for common reason , not point to any company or any products. I cant find
 
A

Adele

#5
*
Do u know the reason why a manufacturer that has a C.E. mark on its device may not pursue Australian approval?
:thanx:
Hi - there is no need to get approval from the TGA if your device is CE marked and you are a manufacturer based outside Australia. There is a Mutual Recognition Agreement between Australia and Europe recognising each other countries conformity assessment. This means that you do not have to repeat conformity assessment in Australia if your device has gone through conformity assessment by a Notified Body. There is more info in the following guidance document - http :// www .tga. gov.au/devices/argmdp1.pdf. - BROKEN LINK UNLINKED

An overseas manufacturer will require an Australian-based sponsor to liaise with the TGA when required. This sponsor could submit the additional information on behalf of the manufacturer or they may nominate specific people from the manufacturer who can do that.

Even though you don't need an audit from the TGA, you will still need to submit the EC certificate as evidence and then get approval for each device (or grouping of devices) via the DEAL website.

Regards,

Adele
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#6
Hi - there is no need to get approval from the TGA if your device is CE marked and you are a manufacturer based outside Australia. There is a Mutual Recognition Agreement between Australia and Europe recognising each other countries conformity assessment. This means that you do not have to repeat conformity assessment in Australia if your device has gone through conformity assessment by a Notified Body. There is more info in the following guidance document - http :// www .tga. gov.au/devices/argmdp1.pdf. - BROKEN LINK UNLINKED

An overseas manufacturer will require an Australian-based sponsor to liaise with the TGA when required. This sponsor could submit the additional information on behalf of the manufacturer or they may nominate specific people from the manufacturer who can do that.

Even though you don't need an audit from the TGA, you will still need to submit the EC certificate as evidence and then get approval for each device (or grouping of devices) via the DEAL website.

Regards,

Adele
Hi,

As far as I understand the MRA only applies to products originating in AU or the EC, i.e. a product made in the USA (for example) is not exempt from the Australian conformity assessment even if it was cleared for CE marking.

Cheers,
Ronen.
 
Last edited by a moderator:
A

Adele

#7
Hi,

As far as I understand the MRA only applies to products originating in AU or the EC, i.e. a product made in the USA (for example) is not exempt from the Australian conformity assessment even if it was cleared for CE marking.

Cheers,
Ronen.
Ahhh - good point! The Guidance Documnet does state "applies to medical devices manufactured in the European Community, Australia and New Zealand".

Fortunately, being in NZ means we can access the Australian market via this MRA.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Ahhh - good point! The Guidance Documnet does state "applies to medical devices manufactured in the European Community, Australia and New Zealand".

Fortunately, being in NZ means we can access the Australian market via this MRA.
Yep, I didn't mean to exclude NZ; in that sense you are of course very right. My intention was more on clarifying that not any product bearing the CE mark is eligible - it depends on its origin.

Cheers,
Ronen.
 
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