TGA Proposes to Reclassify Low-Risk Products

Australia’s Therapeutic Goods Administration (TGA) is proposing to review products currently classified as Class I medical devices to see if they should be reclassified as consumer goods.

Device sponsors include a significant number of products as Class I devices in the Australian Register of Therapeutic Goods (ARTG) that should be classified as consumer products because they pose little or no risk to health or safety, according to TGA.

TGA is inviting comments from stakeholders by May 12 on several options, including:

• Working with procurement branches of state and territory health departments to eliminate incentives for including products that are not therapeutic goods in the ARTG;
• Explicitly excluding certain devices, such as devices that claim to admit or absorb vibrations or waves but have not been validated, from the ARTG; and
• Implementing additional verification procedures to prevent non-therapeutic goods or misclassified products being included in the ARTG.

Read the consultation document here: www.fdanews.com/04-03-17-TGAguidance.pdf.