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Medical devices reforms: Low risk products - other therapeutic goods
Project status: implemented
Appropriate regulation of low risk devices improves their availability.
In response to the 2015 Expert Review of Medicines and Medical Devices Regulation, the TGA reformed the regulation of a number of low risk products, including:
- Tampons and menstrual cups were made exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG). They must still comply with other regulatory requirements for tampons or menstrual cups.
- Hard surface disinfectants were downregulated, with disinfectants not making specific claims shifting from being 'listed' to being exempt from inclusion in the ARTG, and disinfectants making specific claims shifting from 'registered' to 'listed'. Disinfectants must still comply with other regulatory requirements.
- Ear candles were excluded from the therapeutic goods regulatory framework.
For more information about consultations on reforms to low risk devices, visit Medical device reforms: Low risk products.
Guidance for industry
For information on what products are excluded goods, see Excluded goods orders, determinations and specifications.