AMA submission to the Therapeutic Goods Administration – Proposed refinements to the regulation of medical devices that are substances introduced to the human body via body orifice or applied to the skin
The AMA understands that recent moves to further align Australia’s medical device regulation with the European Union Framework has created a situation where some medical devices can also be considered medicines, causing regulatory confusion and overlap. While the AMA supported aligning with the EU Framework, the AMA also supports the proposed amendments to medical devices that are substances introduced into the human body via a body orifice or applied to the skin. Under the amendments, these medical devices will be considered medicines instead. The TGA’s medicines regulatory framework is seen as effective and the changes proposed will not compromise current levels of oversight.