Proposed refinements to the Regulation of medical devices that are substances introduced into the human body via a body orifice or applied to the skin

Closed 13 Aug 2021

Opened 16 Jul 2021

Overview

In early 2019 the Therapeutic Goods Administration (TGA) conducted a public consultation seeking feedback on a proposal to introduce new classification rules for medical devices composed of substances that are intended to be introduced into the human body through a body orifice, or applied to skin, that are absorbed or dispersed. The proposed regulatory changes supported the commitment made to align Australian medical device regulations, where possible and appropriate, with the European Union framework.

The amendments introduced new classification rules for medical devices composed of substances that are intended to be introduced into the human body through a body orifice or applied to skin, effective from 25 November 2021.

 

Why your views matter

Based on feedback from consumers and health care professionals, hospitals and medical device companies, we are consulting on potential refinements to the Regulations.

What happens next

Your input and feedback will help inform any changes to the Regulations in relation to classification rules for medical devices composed of substances that are intended to be introduced into the human body through a body orifice, or applied to skin, that are absorbed or dispersed.

Audiences

  • Anyone from any background

Interests

  • Hospitals
  • Legislation
  • Regulatory policy