ODMA Member Bulletin

Written By Vivienne Forbes

There are numerous items progressing through the TGA currently and thus I thought it an opportune time to summarise them all for the ODMA membership, just to ensure you are aware of any items that may affect your business.

Please see below information relating to

  • Potential exemption of prescription spectacles and lenses for ARTG listings

  • TGA Fees and Charges

  • EU MDR - changing medical device regulations

    Potential Prescription Spectacles and Lenses Exemption from ARTG

    Work is underway on an exemption approach for prescription spectacles and lenses. The TGA will prepare a consultation paper to propose to optical distributors and manufacturers a potential approach that is being investigated by ODMA with a view to reducing your administrative and financial burden whilst keeping business and consumer protection benefits in place.


    ODMA is currently liaising with nominated Standards and Technical representatives for input on this topic. This will be provided back t the TGA to enable them to draft a consultation paper that will be circulated to industry. Considerations that are currently being discussed include public notifications, reporting requirements, and any items best excluded from the scope of this exemption, such as myopia treatment lenses. Items such as contact lenses, implantable lenses, injectable fluids would not be in the scope of this exemption. The key to this exemption initiative is that specified devices, either entirely or conditionally, are exempt from the need to include the item in the ARTG. Exemption means the items will be subject to the obligations under the Act, such as keeping distribution records, reporting adverse events etc, but are not required to seek pre-market inclusion in the ARTG.

    TGA will then need to consider approving this within its broader policy framework and such a change would also be subject to Ministerial approval, so this will involve a bit of work and a bit of time.

    Input around any issues you see for our sector or items that need close management are welcomed in the coming weeks as we prepare for the drafting of this consultation paper.

    We are advised until then, that the TGA at present, are not rejecting applications for ARTG inclusion of spectacles as Class I devices, however, are also not taking compliance action to ensure would-be sponsors have entries.  As the current regulatory status is unclear, and action to clarify this is underway, the TGA would not want to prompt a lot of action to include items in the ARTG (at around $600 per application) only to remove them in a year or so, or to prompt people to remove existing entries if the exemption approach is not approved.

      

    TGA Fees and Charges – Planned Increases

    In December 2022, industry representatives, including myself for the optical industry, were requested to attend a TGA Budgetary Outlook presentation in preparation for the release of the TGA’s consultation paper on proposed fees and charges for 2023-24.

    In a nutshell, many fees are due to rise, some are rising quite substantially, and whilst a consultation paper is being released this month as it normally is, industry representatives such as ODMA cannot provide as much input it seems as in prior years. This is because we were advised that this year, increases already have Government approval. Whilst the final percentage increases are not finalised, our understanding is that they are due to be in place by 1 July 2023.

    The TGA Regulator Performance Report was released on the TGA website on 29 November 2022. The report can be accessed through this link on the TGA website Regulator Performance Report 2021-2022.

    ODMA will, however, pass on all items raised with us including questions relating to fee issues concerning items such as software updates, changes of address and prohibitive fee charges for measurement devices.

     EU MDR Transition


    This relates to manufacturers and agents with medical devices included in the Australian Register of Therapeutic Goods (ARTG), where the conformity assessment certification that supports this inclusion, is transitioning to the new certification issued under the European Union Medical Device Regulations (EU MDR).

    There are multiple resources available to provide guidance to assist those involved to understand and meet their obligations under the Australian regulatory framework and include:

    • A suite of guidance material to help manufacturers and sponsors understand their regulatory obligations when transitioning to the EU MDR

    • An Online Assessment Tool to help sponsors determine what actions are needed in Australia because of their transition to the EU MDR

    • An EU MDR Web Publication Service for sponsors who qualify for streamlined market notifications to advise health care providers and end users of low-risk changes because of the transition, using an Online Notification Form

    ODMA’s Ongoing Commitment


    ODMA will of course continue to attend relevant TGA meetings, review email updates and assist where possible to reduce administrative and financial burdens for optical distributors and manufacturers.

    ODMA will request the TGA provide bulletin updates on major items affecting the optical sector as well as update the website or provide some information resource around optimising Class 1 device ARTG entries.

    For further information on Medical Devices Regulatory and Technical Consultative matters that are discussed at RegTech meetings that you require more detail on, please ensure you are in contact with ODMA or preferably the TGA directly and provide any input relevant to you. Agenda items currently include the new non-mandatory audit framework, streamlined conformity assessment, classifying devices, the impact of changes in US EPA standards for levels of ETO used in sterilisation, the EU position on Personal Medical Devices (PMD) and the TGA’s proposed framework of industry education and engagement.

    I will provide further updates as available else please contact me if you have any specific concerns relating to the TGA or contact the TGA directly per the below.

     Further Information Points of Call:

     

    Regards,

      Amanda Trotman

    Acting CEO
    ODMA
    amanda@odma.com.au

     

     

Vivienne Forbes
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