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  • 1.  Australia Manufacturer's Evidence

    This message was posted by a user wishing to remain anonymous
    Posted 01-Aug-2022 09:26
    This message was posted by a user wishing to remain anonymous

    Dear RA expert,

    Just a quick question - we use CE cert as the manufacturer's evidence to apply ARTG in Australia. What will happen if we couldn't renew our CE cert on time due to MDR? Will this affect the ARTG?


  • 2.  RE: Australia Manufacturer's Evidence

    Posted 02-Aug-2022 03:06
    Anon,

    Australia TGA published a notice for this back in 2021: https://www.tga.gov.au/sites/default/files/tgas-approach-delays-medical-device-conformity-assessment-recertification.pdf.  The answer to your question thus is a bit more complicated because you have to provide evidence supporting you are maintaining or striving for the maintenance of your CE Certificate.  Also read carefully because they use terms like lapse, cancel, and suspend, which you should take care what happens to your CE Certificate if it can not be renewed in a timely manner.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Australia Manufacturer's Evidence

    Posted 02-Aug-2022 13:27
    Hi,

    Fully agreed with what Richard mentioned. Kindly note that the document from TGA highlights the actions mainly intended for Australian Sponsors, which makes it necessary for manufacturers to keep their sponsor informed on the status of MDR conformity assessment process and upon noticing any risk of not getting certified in time, notifying TGA without undue delay.  
    Furthermore, as TGA also accept certificates from other regulators like US FDA, Health Canada or Japan MHFW/PMDA, if the device under question is having a regulatory approval in any of the countries mentioned above, this can also be used for conformity assessment and support ARTG listing.

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    Somashekara Koushik Ayalasomayajula
    -Ing.
    Garching bei München
    Germany
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    Original Message


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