IMPORTANT TGA UPDATES
Prescription spectacle lenses are now exempt from the requirement for inclusion in the Australian Register of Therapeutic Goods (ARTG) prior to import, export or supply in Australia.
Dear ODMA Member,
Amazing news - The prescription lenses changes have now gone through, and there are published the details on the TGA website.
Thanks to ODMA Standards Reps George Webster and Simon Pavy as well as Annette Hoskin who greatly assisted in this process.
TGA is updating industry stakeholders and those with ARTG registrations however we want to pass on some further information to ODMA members here as well as other TGA information.
Update 1
There have been recent regulatory changes in relation to a number of medical devices reforms.
These include:
Exemption for prescription spectacle lenses
Software transitional arrangements
Device application audits
Classification of devices containing substances of animal, microbial or recombinant origin (Classification rule 5.5)
Please see the web statement Medical device regulation changes | Therapeutic Goods Administration (TGA) to better understand whether your product or ARTG entry has been affected.
For any products that may be affected by the spectacle lens changes, software transitional arrangements or classification rule 5.5, affected sponsors will also be contacted individually.
These regulatory amendments came into effect on 15 June 2024 (https://www.legislation.gov.au/F2024L00686/latest/text, Schedule 1, Part 2).
More information the regulation of various lenses is available on the TGA website at https://www.tga.gov.au/news/news/prescription-lenses-exempt-medical-devices. These changes do not apply to contact lenses.
While prescription spectacles do not need to be included in the ARTG, they are still regulated by the TGA. More information on the regulatory obligations for exempt medical devices is available on the TGA website at https://www.tga.gov.au/resources/resource/guidance/regulatory-obligation-exempt-medical-devices
If you have any queries on this change my contact details are listed below.
Thanks
Rachel
Rachel Croome (she/her)
Director – Regulatory Policy
Medical Devices Authorisation Branch
Phone: 02 6289 2667
Mobile: 0402 416 958
Email: rachel.croome@health.gov.au
Therapeutic Goods Administration
Department of Health and Aged Care
Ngunnawal Country
Whilst there is not urgent need for cancellation of entries per se, the TGA has contacted all sponsors that have entries, and whilst we appreciate it was short notice, it means there was actually the opportunity for you to remove entries by 30 June to avoid next years ARTG entry fees of $111 per entry annual charge. Shame the notice ended up being tight however we did end up getting the exemption through quicker than we expected so this has given rise to an earlier than expected option to avoid these fees for industry members.
Update 2
The TGA’s public consultation on legislating regulatory categories for some boundary and combination products is now open.
In October 2022, the TGA undertook a public consultation on the draft guidance for ‘Boundary and combination products - medicines, medical devices, and biologicals.’ Based on the feedback received, the guidance document and example list of boundary and combination products were updated and published on the TGA website. Stakeholders also indicated the need for additional clarity on the regulatory pathways for some boundary and combination products.
This consultation paper seeks feedback on whether legislating the regulatory categories and classification for some boundary and combination products would help provide the additional clarity needed and whether a transition period of five years is enough for affected ARTG entries.
We invite RegTech members to provide input on the consultation paper by answering a survey on the TGA Consultation Hub using this link: https://consultations.tga.gov.au/medical-devices-and-product-quality-division/proposal-legislate-boundary-combination-products
For example, contact lens care products. The consultation will close on 06 August 2024.
If you have any questions or concerns, please email us at devicereforms@tga.gov.au.
Kind regards
TGA Medical Device Reforms Projects Team
Kind Regards
Amanda Trotman
CEO
