Australia – Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin

Guidance on the transitional arrangements and obligations

The purpose of this guidance is to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021, some medical devices that are substances for introduction into the body will be required to be reclassified. The new regulatory requirements will also include…