Opportunity to contribute to TGA consultation

The Therapeutic Goods Administration (TGA) is reviewing the regulation of medical devices manufactured and supplied by healthcare providers at the point-of-care (POC). OTA has been invited to join a working group to discuss and inform appropriate regulatory pathways for medical device POC manufacturing in the allied health sector and represent the views of occupational therapists.

If you're involved in point-of-care manufacturing of medical devices we want to hear from you.

To assist us in representing members who are involved in POC manufacturing of devices, we want to understand:

  • What POC manufacturing model/s you use in your workplace
  • Any issues you experience in relation to TGA regulation of POC manufacturing of devices
  • Key risks in manufacturing of POC devices you have identified that you believe require regulation


The role of the allied health working group is to:

  • Discuss the regulatory pathways for POC manufacturing in the allied health sector
  • Identify areas of regulatory duplication and/or regulatory gaps in the existing regulations relevant to the allied health sector
  • Recommend and help inform the development of appropriate regulatory pathways for health service organisations and health practitioners with the aim of streamlining and/or reducing regulatory obligations without increasing risk to patients and consumers


If you have any insights to share or would like to be involved in the consultation, please email Sarah Jones, Professional Practice Advisor, sarah.jones@otaus.com.au.

For more information you can review the TGA webpage: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/point-care-manufacturing-medical-devices

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