The Optical Distributors and Manufacturers Association (ODMA) has alerted members to a new fee of AU$530, proposed by the Therapeutic Goods Administration (TGA), which would be placed on new Class 1 Medical Devices (including optical frames and lenses) on the Australian Therapeutic Goods Register (ARTG) from 1 July 2018. This is in addition to the fees equipment companies already pay to maintain the entry annually on the ARTG.
ODMA is making representations to TGA and the Minister for Health, and has urged industry suppliers to support its advocacy campaign.
In an announcement, Finola Carey, CEO of ODMA has asked suppliers to:
1. Submit any new applications (where possible) for product before 1 July 2018 as no fee will be payable.
2. Write to the TGA: [email protected], the Minister for Health’s adviser, [email protected] and your local MP.
Ms. Carey said letters should make the points that, “the charges will affect the commercial sustainability of businesses in the optical industry and see businesses reduce the number of new and innovative products they place on the ARTG. Less innovative product placed on the register will impact optometrists’ and dispensers’ ability to provide optimal eye care solutions”.
Additionally, Ms. Carey said industry members should ask that the changes be delayed until 1 July 2019 so that businesses have time to make considered commercial decisions regarding the introduction of new products.
“Explain that it will affect your business by reducing your product offerings and mean that you will have no choice but to pass on the cost to optometrists and dispensers so ultimately the consumer will pay,” she wrote.
For information on TGA visit www.tga.gov.au/sme-assist
