The Therapeutic Goods Administration has updated its advice to medical practitioners on surgical mesh regulation and also in regards to medical devices that are introduced into the human body via a body orifice or applied to the skin. Painaustralia provided submissions to both reviews.
From 1 December 2021, suppliers of implantable medical devices are required to have patient information materials available in the form of Patient Information Cards (PIC) and Patient Information Leaflets (PIL).
These information materials provide patients and medical practitioners with important information about specific implantable medical devices. More information about this initiative can be found on the TGA website.
There are also changes to the regulation of medical devices that are substances introduced into the human body via an orifice or applied to the skin.
In December 2019 an amendment to the regulations for medical devices introduced new classification rules for medical devices that are substances intended to go into the human body through an orifice or be applied to the skin, and are absorbed or dispersed. The new rules came into effect from 25 November 2021.
This amendment followed a public consultation process conducted by the Therapeutic Goods Administration (TGA) in early 2019 and also earlier this year.