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  • 1.  Supplying 3rd party medical devices in Australia

    This message was posted by a user wishing to remain anonymous
    Posted 06-Mar-2019 15:18
    This message was posted by a user wishing to remain anonymous

    Hi members:

    Are you aware of any regulatory requirements when we need to ship a 3rd party medical device product in Australia? Some of our physicians' are requesting for an approved product to be supplied in Australia but the product is from another manufacturer that is compatible with our device. Additionally, we need to ship this from Europe to Australia.

    Thanks in advance.


  • 2.  RE: Supplying 3rd party medical devices in Australia

    This message was posted by a user wishing to remain anonymous
    Posted 07-Mar-2019 00:05
    This message was posted by a user wishing to remain anonymous

    Hi There,

    Before any medical device is supplied in Australia, it needs to be included in the Australian Register of Medical Devices - ARTG  (unless the device is exempted). The Australian SPonsor holds the legal responsibility for submitting an application to TGA for approval and then complying with post market regulatory requirements. When you say 'Some of our physicians' are requesting for an approved product ..." do you mean that the device is included in the ARTG? 
    Also note that if the device is included in the ARTG under a specific sponsor's name, and if the device is also intended to be supplied by another supplier, they may need to get a seperate ARTG approval for the same product. Some manufacturers tend to have one sponsor (who holds the license) but several distributors for the same product. 

    Hope this helps.

    Original Message


  • 3.  RE: Supplying 3rd party medical devices in Australia

    This message was posted by a user wishing to remain anonymous
    Posted 07-Mar-2019 00:05
    This message was posted by a user wishing to remain anonymous

    ​Are you located in Australia or outside?
    Does the other manufacturer have a sponsor?
    Original Message


  • 4.  RE: Supplying 3rd party medical devices in Australia

    Posted 07-Mar-2019 05:49
    Hi,

    Is 3rd Party the legal manufacturer of the device i.e. product label shows your 3rd Party as the manufacturer not your company? If so, and if this device is supplied individually i.e. not part of the procedure pack or system then it needs to be on the ARTG (unless exempted - Clinical trial, SAS etc.) before it can be supplied in Australia. Note a legal manufacturer may have multiple Australian Sponsors. Do you have an agreement with this 3rd Party manufacturer and do you have an Australian Sponsor? If so, then you can register your 3rd Party manufactured device on the ARTG and supply​. If your 3rd Party manufacturer already supplies product in Australia through a different sponsor to your then you can make an arrangement i.e. get in writing to use their existing ARTG and continue to supply.

    Let me know if you have any questions.

    Regards,
    Romit

    ------------------------------
    Romit Singh
    Pre Market Team Leader
    Belrose
    Australia
    ------------------------------

    Original Message


  • 5.  RE: Supplying 3rd party medical devices in Australia

    Posted 07-Mar-2019 17:28
    Hi Anonymous,

    It is not clear in your email about the relationships between your company, the Third Party Legal Manufacturer and the Australian Sponsor. So I will assume that your company is based outside Australia and you have a local Sponsor that is responsible for the registration and maintenance of your devices. 

    ​The Australian Therapeutic Goods regulations require all medical devices to be listed on the ARTG before it can be imported into Australia for sale.  This is the responsibility of the Sponsor with the approval of the Legal Manufacturer.

    Strictly speaking, if you wish to import a third-party's medical device, then the Legal Manufacturer must authorize the device's registration in Australia. This may be done through your Sponsor (with the appropriate contracts in place) or their own Sponsor.

    If the device is not approved in Australia at this point in time, then arrangements need to be made to get that done first. The TGA has recently issued a guidance document which describes pathways where Sponsors can leverage approvals from the US, EU and other international regulatory bodies. I would recommend looking at that document to see if you can shorten the approvals process.

    Finally, don't forget the post-marketing responsibilities (e.g. complaints, adverse events, recalls, annual reporting for particular classes of medical devices). These are the purview of the Sponsor, so please ensure that this has been clarified (contractually) between you, the Third Party and the Australian Sponsor of the Third Party's device.

    I hope this information addresses your concern.





    ------------------------------
    Elizabeth Freitas
    Assoc Director, Regulatory Affairs-Asia Pacific, Japan.
    Illumina Australia Pty Ltd
    Scoresby, Victoria,
    Australia
    ------------------------------

    Original Message


  • 6.  RE: Supplying 3rd party medical devices in Australia

    Posted 10-Mar-2019 19:45
    Reading this discussion there are a lot of unknowns in the original specific case.  But acting as local sponsor for international manufacturers is something we do all the time and TGA rules and expectations are pretty clear.

    For a medical device (or IVD) TGA requires that the device be included in the ARTG (That's a technical term for the subpart of the ARTG database applicable for devices.  Drugs and biologics are registered or listed.  These terms have completely different meanings in Australia to the US).

    The inclusion must be held in the name of an Australian legal entity - known as the sponsor.  The sponsor (as others have already said) takes all responsibility for regulatory compliance and for maintaining communications between TGA and manufacturer.  It's precisely analogous to the roles and responsibility of a European Authorised Representative (EC Rep).  And it's something we do a lot of.

    Now this is where things get interesting...

    • One product from one factory can have one or many sponsors (i.e. parallel importing is quite OK with TGA providing that each independent channel is covered by an inclusion and sponsorship).  
    • It's also permissible for one product to come through multiple distribution channels with only one sponsor.  But in such scircumstances, TGA expects to see contractual relationships between all the parties to ensure that all regulatory communications are properly managed (including adequate arrangements for postmarket reporting,distribution records and recalls and advertising controls).

    It gets even more interesting in the case of products with a biological component (e.g. an IVD with biological molecules, devices with collagen components etc.)  IN that case the Customs and Quarantine folks (now known as "Border Force") may seize a product at the border  if it's not clear what sponsorship arrangements are in place and who holds the inclusion.  They then immediately refer the matter to TGA for clarification/investigation.  We had just such a acase recently which was resolved by providing the contracts we had in place.

    So to make sure you don't get into trouble you need to do three things:

    • Make sure that the product is included on ARTG via an Australian sponsor.  The sponsor can be a distributor or it can be an independent regulatory specialist (we of course , for all sorts of reasons, recommend the latter.
    • Make sure that formal contracts are in place setting out who has responsibility for meeting the various aspects of regulatory compliance AND what the formal processes are.
    • When shipping to Australia, include within the shipping paperwork the details of the ARTG inclusion number AND the name and contact details of the sponsor - so Border Force have evidence that the product can be legally supplied and know who to call if they have any questions about the shipment.  It's especially important to do this if the product si being shipped direct to a distributor or to a clinican, as the Border Force will assume that because that person is not holding a registration then they are dealing with an unapproved import.

    Arthur 


    ------------------------------
    Arthur Brandwood PhD FRAPS
    Founder and Principal Consultant
    Brandwood Biomedical
    Sydney, Australia
    ------------------------------

    Original Message


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