A summary of recent TGA guidance to industry

The Therapeutic Goods Administration (TGA) of Australia has recently released updates to numerous guidance documents for the industry.

Custom made medical devices

Australia’s medical device regulations define custom made medical devices as those that are:

  • Made specifically in accordance with a request by a health professional specifying its design characteristics or construction.
  • Intended to be used only in relation to a particular individual, or by a health professional to meet special needs arising in the course of his or her practice.

However, from 25 February 2021, a new regulatory framework for custom made medical devices will come into force. This will include a new definition which will mean the majority of devices currently classified as custom made devices no longer meet the definition and will need to be included in the Australian Register of Therapeutic Goods (ARTG). To allow continued supply of current devices until 1 November 2024, manufacturers must submit a notification form for transition arrangements. Full details of the new regulation for custom made medical devices can be found here.

Software based medical devices

Regulatory changes relating to software based medical devices will be implemented from 25 February 2021 with the transition period ending on 31 October 2024. The TGA has released several documents to aid manufacturers be compliant with this regulation:

Pharmacovigilance obligations of medicine sponsors

Whilst not in response to new legislation, the TGA has published answers to FAQ’s relating to the pharmacovigilance obligations of sponsors of medicines on the ARTG. The aim is to support understanding of the pharmacovigilance responsibilities of medicine sponsors. The following topics are covered in the FAQ:

  • Collecting and reporting adverse drug reactions.
  • Post-registration studies and post-marketing initiatives.
  • Searching Australian and worldwide medical literature.
  • Identifying and reporting significant safety issues.
  • Updating Australian Product Information (PI) and Consumer Medicines Information (CMI) documents.
  • Australian pharmacovigilance contact person and Qualified Person for Pharmacovigilance in Australia (QPPVA).

Provisional Registration extension and transition to full registration, of prescription medicines

This guidance has been drafted for sponsors of provisionally registered prescription medicines. The most recent update relates to variations for provisionally registered medicines. There is an update to the scenarios in which variations for provisionally registered medicines will be initiated by the TGA.

Additionally, a new section on sponsor initiated variations for provisionally registered medicines has been included. It details the scenarios sponsors may need to vary aspects of their medicines during product development while they are still provisionally registered.