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TGA Registration: Non-Approved Lens Importers Risk Prosecution
mivision | 27 May 2013
As per the Therapeutic Goods Act 1989, optical lenses for spectacles are medical devices and as such, they must be included in the Australian Register of Therapeutic Goods (ARTG) prior to selling in Australia and New Zealand (WAND).
According to the lens manufacturers mivision spoke to, there is an increasing number of small wholesalers and optometrists importing without approval.
George Nasser from Opticare said the problem is rife. “There are so many backyard companies importing lenses without TGA approval, it’s not funny. Since the optical industry was deregulated, it seems that anybody can legally provide a pair of glasses in Australia.”
Mark Thyssen, Vision Care Division Product Manager at Zeiss said although non-TGA approved optical lenses present a low risk to consumer health, if the lenses do not meet optical standards, a consumer’s vision can be impaired.
“Although it’s impossible for consumers to tell whether or not they’ve bought TGA approved lenses, there could be legal ramifications if you’re found out. For example, if someone has an accident and
it transpires that the lenses they were wearing were not up to Australian standards or TGA approved, the importer could be held liable,” he said.
Finola Carey, CEO of ODMA said the issue of TGA approval “is a huge problem for frames, lenses and even equipment.
“The TGA legislation was only introduced with regard to frames and lenses around 2004. Basically the TGA requires the products to be registered but do very little to ensure compliance despite having a supposed surveillance unit. In fact I am aware of cases of “dobbing in” non-compliant companies and the TGA still are slow to act even in the case of sensitive medical devices used in invasive surgery!,” said Ms. Carey.
She continued, “the ODMA Members code of conduct requires them to comply with TGA guidelines and as far as I am aware they all do. Some retailers area importing frames, lenses and even equipment and appear oblivious to the TGA guidlelines. The penalties for non-compliance should they be caught are hefty”.
mivision reviewed the list of TGA registered lens importers online (www.tga.gov.au) and noted that some of Australia’s largest optical lens distributors are not registered with the TGA.
TGA Must Be Satisfied
For a medical device to be included in the Australian Register of Therapeautic Goods (ARTG), the TGA must be satisfied that evidence exists appropriate to the perceived risks of the device to support its safe and effective use, and that an appropriate system is in place for monitoring the ongoing performance and safety of the device.
If someone intends to supply a device that is identical to a device that is already in the ARTG, even if both devices are made by the same manufacturer, an application to include the device in the ARTG must still be made to the TGA. This is because the ARTG is not only a record of the devices that can be supplied in Australia; it is also a record of all the sponsors who are legally responsible for the medical devices on the market.
As a general rule:
- All medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) prior to selling in Australia and New Zealand (WAND);
- If you import spectacle lenses into Australia, it is important to ensure you are aware of what registration is required and that your products are registered;
- If you are an optometrist, ask your supplier (Australian Sponsor) if their products (spectacle lenses) are included in the Australian Register of Therapeutic
Additionally, check the list of registered importers by visiting the TGA website www.tga.gov.au or referring to the Australian Regulatory Guidelines for Medical Devices (ARGMD).
...the TGA must be satisfied that evidence exists appropriate to the perceived risks of the device to support its safe and effective use...