TGA seeks feedback on classification of devices applied to the skin
Australia’s Therapeutic Goods Administration (TGA) has begun a consultation on refinements to the regulation of some medical devices. The proposals apply to devices that are substances introduced into the human body via an orifice or applied to the skin.
TGA published the proposals as part of its efforts to reclassify certain categories of medical devices so that they align with the new regulatory framework in the EU. Medical devices that consist of substances introduced into the body via a body orifice or applied to the skin are one of the six categories of products covered by Australian legislation introduced late in 2019. The law, which creates new classification rules for the medical devices, is set to take effect on 25 November.
Having reviewed feedback from consumers, healthcare professionals, hospitals and medical device companies, TGA is proposing further refinements to the regulations. While the original proposal is aligned with the EU regulation, TGA is now questioning whether full alignment is appropriate given overlap in the medicine and medical device regulatory frameworks in Australia for some products.
Faced with that overlap, TGA is planning to remove references to products that are systemically absorbed because they meet the Australian definition of a medicine. The plan is to delete two lines about products that “are systemically absorbed by the human body.” In doing so, TGA is aiming to address regulatory inconsistencies that could arise if products are classed as medicines and devices.
The guidance features examples of how the regulations will affect certain types of products. A saline nasal solution spray, for example, will go from Class I to Class IIa when the law takes effect. TGA will classify sprays that use isotonic saline to irrigate the nasal cavity as medical devices, whereas products that use hypertonic saline that has an osmotic effect in the nasal cavity will be classified as medicines.
TGA is accepting feedback until 13 August. The agency said the feedback will help it identify issues that may arise if the regulations are changed and support its efforts to tailor the stakeholder education program for the class of products…