The TGA is consulting on proposed refinements to the regulation of medical devices that are substances introduced into the human body via an orifice or applied to the skin.
Events leading to this consultation
- In early 2019, the TGA conducted a public consultation process. This was to seek feedback on a proposal to introduce new classification rules for medical devices composed of substances that are intended to be introduced into the human body through a body orifice, or applied to skin, and are absorbed or dispersed. The proposed regulatory changes supported the commitment made to align Australian medical device regulations, where possible and appropriate, with the European Union framework.
- In December 2019, the above consultation led to an an amendment to the regulations for medical devices. This introduced new classification rules for medical devices that are substances intended to go into the human body through an orifice or be applied to the skin, and are absorbed or dispersed. The new rules take effect on 25 November 2021.
About this consultation
Following feedback from consumers, healthcare professionals, hospitals and medical device companies, the TGA is now consulting on proposals to further refine the regulations for medical devices fitting the above description.
While the new classification rule does align with the EU, the recommendation was to align where possible and appropriate. This being the case case, alignment with the EU may not be appropriate given the overlap in the medicine and medical device regulatory frameworks in Australia for some products.
Therefore, it is proposed that the new classification rule be amended to remove references to products that are systemically absorbed by the body, as these products meet the definition of a medicine.
What does the TGA hope to achieve with this consultation?
Feedback on the proposed amendment in this consultation will help the TGA to identify any issues that may arise if the Therapeutic Goods Regulations are changed. Feedback will also enable the TGA to tailor its stakeholder education program in relation to these products.
Where can you provide feedback to the consultation?
You can provide feedback here via the consultation hub.
What are the start and end dates of the consultation?
Start date: 19 July 2021
End date: 13 August 2021
Source: TGA Website
Update on 12 November 2021
Feedback on the consultation and what the TGA has/done/is doing based on the feedback received is available here.