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Medical Devices / Regulatory Affairs

TGA Issues Guidance on Regulation of Menstrual Cups

Dec. 26, 2018

Australia’s TGA advised sponsors that menstrual cups no longer need to be included on the Australian Register of Therapeutic Goods (ARTG).

Prior to July 1, menstrual cups were required to be listed on the register, but listing is no longer required for these products. However, menstrual cups are required to comply with Therapeutic Goods Order No. 99 — Standards for Menstrual Cups 2018 before they can be supplied in Australia.

The TGA advised sponsors that they should notify the TGA to de-list the products from the registry or they will need to pay applicable fees.

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