Australia – TGA expectations for transition to 2021 Advertising Code and updated guidance on reclassification of AIMDs

The Australian Therapeutic Goods Administration (TGA) has issued several notices recently affecting medical device manufacturers doing business in Australia. The first update clarifies TGA’s expectations for its transition to the 2021 Advertising Code. The second is updated TGA guidance on the reclassification of active implantable medical devices (AIMDs).

The TGA released its guidance on Transitioning to the new Therapeutic Goods Advertising Code last week. In it, the TGA clarified its expectations for medical device manufacturers regarding the use of existing stock of hard copy advertisements following the transition to the new Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.

The agency explained how advertisers may use their existing hard copy stock of ads during the transition period currently in place until June 30, 2022. During this period, advertisers may either comply with the 2021 Code or the 2018 Code…