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Re: Exporting medical devices to Australia - Regulatory system for medical devices
Hi everyone,
A couple of further clarifications following on from the detailed posts from Grant and Leo.
If you are outside of Australia and have a Class IIa or IIb device, then your local distributor can achieve TGA approval by submission of the CE certificate via TGA's electronic lodgement system DEAL. In practice, TGA accepts such certificates irrespective of country of origin.
There's potential confusion abut the manufacturer vs. Sponsor. They are different things - although one entity can be both for a given device. The sponsor is a bit like the European Representative - they are the legal entity responsible for the device in Australia and have to be an AUstralian company or person. The manufacturer is the person who does or arranges to be done, design, productions, release etc. and who maintains and holds the Tech File. and prepares the Declaration of COnformity.
So there is flexibility here, depending on who is declared to be a manufacturer. e.g. there could be an Australian company which arranges for manufacture in (say) CHina and declares themselves to be the manufacturer. In which case they (the Australian Co.) would hold the Technical File, control the Chinese Production activity under Vendor controls in the QMS and would be themselves be subject to full TGA conformity assessment. THis happens for some companies who outsource part but not all of their Aussie manufacture.
THe crucial detail is the labelling. The manufacturer must be identified, In the case of an AUstralian spoonsor and a declared overseas manufacturer this leads to labelling aliong the lines of "Manufactured by XYZ device co, CHina for ABC device Co Australia" with full contact addresses of both.
In this case, the Tec File is the responsibility of XYZ China, who in turn must have been CE certified by a Notified body recognised by TGA
Turning to NZ.
There is currently no premarket assessment requirement and very scant devices regulation in NZ - although there is now a notification database called WAND- which is a clone of the TGA's database. When the new joint Agency comes in, the WAND and ARTG databases will be merged and a joint regulatory assessment, approval and licensing scheme will emerege. But there's no back door way to Australia via NZ. Currently marketing in Australia requires approval by TGA granted to an Australian domiciled sponsor. Marketing in NZ requires separate notification on WAND by a NZ domiciled sponsor.
Arthur
Hi everyone,
A couple of further clarifications following on from the detailed posts from Grant and Leo.
If you are outside of Australia and have a Class IIa or IIb device, then your local distributor can achieve TGA approval by submission of the CE certificate via TGA's electronic lodgement system DEAL. In practice, TGA accepts such certificates irrespective of country of origin.
There's potential confusion abut the manufacturer vs. Sponsor. They are different things - although one entity can be both for a given device. The sponsor is a bit like the European Representative - they are the legal entity responsible for the device in Australia and have to be an AUstralian company or person. The manufacturer is the person who does or arranges to be done, design, productions, release etc. and who maintains and holds the Tech File. and prepares the Declaration of COnformity.
So there is flexibility here, depending on who is declared to be a manufacturer. e.g. there could be an Australian company which arranges for manufacture in (say) CHina and declares themselves to be the manufacturer. In which case they (the Australian Co.) would hold the Technical File, control the Chinese Production activity under Vendor controls in the QMS and would be themselves be subject to full TGA conformity assessment. THis happens for some companies who outsource part but not all of their Aussie manufacture.
THe crucial detail is the labelling. The manufacturer must be identified, In the case of an AUstralian spoonsor and a declared overseas manufacturer this leads to labelling aliong the lines of "Manufactured by XYZ device co, CHina for ABC device Co Australia" with full contact addresses of both.
In this case, the Tec File is the responsibility of XYZ China, who in turn must have been CE certified by a Notified body recognised by TGA
Turning to NZ.
There is currently no premarket assessment requirement and very scant devices regulation in NZ - although there is now a notification database called WAND- which is a clone of the TGA's database. When the new joint Agency comes in, the WAND and ARTG databases will be merged and a joint regulatory assessment, approval and licensing scheme will emerege. But there's no back door way to Australia via NZ. Currently marketing in Australia requires approval by TGA granted to an Australian domiciled sponsor. Marketing in NZ requires separate notification on WAND by a NZ domiciled sponsor.
Arthur