Proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods

This consultation seeks feedback on potential changes to the regulation of exempt medical devices and products known as “other therapeutic goods” (OTGs) to:

• Address emerging issues associated with these kinds of exemptions; and
• Ensure regulation of these kinds of products remains fit-for-purpose.

We are seeking your views on three key proposed changes to the way medical devices exempt under Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002 and all “other therapeutic goods” (OTGs) exempt under Schedule 5 or Schedule 5A of the Therapeutic Goods Regulations 1990 are regulated:

1. Require notification of supply

2. Publish information about supply

3. Require provision of information and samples upon request

The proposed changes are intended to address emerging issues associated with these kinds of exemptions, ensure regulation of these kinds of products remains fit-for-purpose and future-proof the framework for the regulation of these kinds of products.