Home – New Forums Logistics Liabilities when selling a product. Consultant needed

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  • #978264
    Dan01
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    Hi All

    Can someone please help me with importing a small medical product. My main concern is “liability”. That meaning that I’ve heard that if you bring a product into Australia and sell it, then you have basically labelled yourself as the manufacturer. Meaning that if that product injures someone, then you will be liable for it. …meaning you could get sued, etc, etc.

    Now having that in mind, obviously I need insurance. But in order to get insured, they need a whole bunch of stuff like the product manufacturing processes, approvals, etc, etc.

    So my question is, are there services out there that can look after all that for me, and advise me of all the things needed in order to get approvals, safety certficates, insurance, etc? Like a business consultant or something?

    I would imagine that anyone selling a product would have to have gone through these processes already?

    Thanks
    Dan

    #1105766
    MyGreatIdea
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    The insurance companies don’t require such extensive information for most products. You will find it much more difficult importing a medical product, and your insurance premiums, I’m afraid, will be hefty.

    Before you start this process, can you get some idea from your insurance company how much your annual premium is likely to be? You may find it will be too much to absorb, and therefore paying someone to obtain all the information may be wasting your money. Can your supplier provide some of the information?

    Wendy :)

    #1105767
    Dan01
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    Thanks for the reply Wendy.

    I spoke to an insurance company who started telling me all these things that were needed (manufacturers processes, certificates, etc). Also I spoke to the TGA (Therapeutic Goods Association) who also required a bunch of approvals and more certificates.

    Thats why I was wondering if there’s some sort of professional service out there that can help me out and make the process a bit easier and clearer.

    regards
    Dan

    #1105768
    Anonymous
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    Hi Dan,

    When you spoke to the TGA, did they confirm whether the product you’re importing will be classed as a medical device?

    If so, you’ll find that once you’ve put together all the information you require for them, a lot of the info required by the insurance company will have been covered off.

    If I were in your shoes I’d be clarifying the regulatory status first and confirming that you can fulfil all the criteria for registration, and would then start thinking about insurance once you were confident that the registration process would be okay.

    For that you will want to talk to a regulatory consultant. I tend to work in the complementary medicines sector rather than with medical devices, so I’m sorry but I don’t know any firms that specialise in those types of regulations. However, Robert Forbes and Associates is highly regarded for this type of work in the complementary medicines area, and the people there may be able to point you in the right direction for a consultant who specialises in medical devices.

    I hope that helps, but please feel free to let me know if you have any further questions.

    Kind regards,
    Jayne

    #1105769
    Dan01
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    Thanks Jayne

    Yes it is classed as as Medical Device, which makes is a lot more demanding in terms of meeting regulations and Australian standards.

    When I asked an insurance company what I need, he even mentioned that they would need some sort of certificate explaining the manufacturing process and procedures when building the device!!! WHAT THE?!? cant imagine going to a company in China or other, and asking for this information!

    that’s when I knew I might need some professional help.

    Thanks for link. Hopefully they can point me in the right direction

    regards
    Dan

    #1105770
    RBB
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    Hi Dan

    A friend of mine looked into importing HPT & ovulation tests which are {obviously} medical devices and she found all the information via the TGA.

    From memory she had to become a ‘sponser’ and register the device which required certification from the manufacturer.

    I do remember that getting the certification from the manufacturer was the easy part {they realise that other countries need this information before they can export so are forthcoming with it- she just contacted them and asked for the certificate}, however the fees involved with becoming a sponser on top of buying the devices was off putting so she didn’t proceed.

    Perhaps you could contact the TGA and ask what the normal process is for your device and what the certificate is called, so you know what to ask for from the manufacturer when you enquire. I’m sure this is what your insurance company would need also.

    Regards
    Lindy

    #1105771
    Anonymous
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    Hi Dan,

    I was thinking about you the other day and wondering whether you’d made any progress, so was hoping you might drop back in and give us an update.

    Having just re-read through this thread, I noticed something I should have responded to earlier:

    Quote:
    When I asked an insurance company what I need, he even mentioned that they would need some sort of certificate explaining the manufacturing process and procedures when building the device!!! WHAT THE?!? cant imagine going to a company in China or other, and asking for this information!

    If the company you’re dealing with in China (or elsewhere) routinely produces medicinal devices for export to Australia or many other parts of the world, they will be operating to certain well-defined manufacturing standards, and producing this documentation will be something they are used to doing all the time. If they can’t produce this information, it is likely that they’re not set up for the manufacture of medical devices, and you may be better off finding a supplier who is.

    I hope that helps. Apologies again for not noticing this aspect of your post earlier.

    Good luck with it all,
    Jayne

    #1105772
    Dan01
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    Jayne Tancred, post: 122909 wrote:
    …I was thinking about you the other day and wondering whether you’d made any progress, so was hoping you might drop back in and give us an update….

    Hi Jayne
    Thanks for the reply. Unfortunately is has not progressed very far at all.

    As I mentioned my main concern is liability. Insurance brokers have come back to me after looking and said insurance companies would only insure me for the standard cover (if someone tripped, or loss and damage, etc) …..basically the standard public liability claims.
    However they would not cover me to any damage caused by the medical product itself (eg, if it caused cancer, or it blew up in someones face, etc). …which is exactly what I wanted cover for. Please note that this device is a very common device which can be sourced from places like the US, UK so there are some level of standards they have to conform to, also from the 5 years of selling this device, we have never heard of these things injuring someone.

    I am still currently waiting for some insurance brokers to get back to me though. If they say they will not insure me, well what am I to do? ….would people really stop to a grinding halt on progress because you cant insure yourself from liability??

    it also makes me wonder, all these people importing products into the country, are they getting the necessary channels and paperwork, insurance covers etc? I have no idea!

    Regards
    Dan

    #1105773
    Anonymous
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    Hi Dan,

    How frustrating! Did you end up getting in touch with a regulatory consultant? If you’re working with someone who deals with medical devices all the time, they may be able to refer you to some specialist insurers.

    I have my fingers crossed for you that it all works out.

    Jayne

    #1105774
    Dan01
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    Jayne Tancred, post: 122981 wrote:
    How frustrating! Did you end up getting in touch with a regulatory consultant?

    No i haven’t yet. But after speaking to TGA (Therapeutic Goods Administration), they gave me the list of documents I would need which is very do-able. So the problem lies with insurance companies. Hopefully a regulatory consultant will be able to give me some info so I can proceed.

    thanks for your help Jayne! I really appreciate it. i’ll update when i’ve made it to the next step

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