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endlesslovehv
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Do u know the reason why a manufacturer that has a C.E. mark on its device may not pursue Australian approval?
Do u know the reason why a manufacturer that has a C.E. mark on its device may not pursue Australian approval?
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Do u know the reason why a manufacturer that has a C.E. mark on its device may not pursue Australian approval?
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.
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.