2021: Oct Sep Aug Jul Jun Mar Feb May Jun

2020: Nov

October 2021

• Webinar 2: Application for consent to import, supply, or export a medical device non-compliant with the Essential Principles, 20 October 2021
  The TGA is modernising this process to move from a standalone paper-based form to an online form
• Application for consent to import, supply, or export a medical device non-compliant with the Essential Principles, 19 October 2021
  The TGA is modernising this process to move from a standalone paper-based form to an online form
• Unique Device Identification Webinar #5, 19 October 2021
  A presentation on the role of a UDI Issuing Agency, including project update and Q&A
• Nicotine vaping products, the NZ smoking cessation experience, 15 October 2021
  The role nicotine vaping products can play in a person's journey to quit

September 2021

• The role of a UDI Issuing Agency, 21 September 2021
  Information on the creation of UDIs and the role of an Issuing Agency
• An introduction to regulation of medical devices in Australia, 6 September 2021
  Presentation from TGA Lecture at Biomedical engineering Department.

August 2021

• Challenges and considerations on the journey to a global UDI system, 17 August 2021
  A presentation and Q&A on UDI from a perspective of a global medical technology company.

July 2021

• TGA Transformation Stakeholder Engagement Forums, 29 July 2021
  The TGA is embarking on a transformation program to change and improve the way we deliver services to our stakeholders.
• Considerations for the Australian UDI, 20 July 2021
  Further considerations for the Australian UDI, including global alignment, GMDN and data elements.

Jun 2021

• Unique Device Identification, 15 June 2021
  An introduction to the Australian Unique Device Identification system, including Q&A
• Proposed improvements to the Therapeutic Goods Advertising Code, 3 June 2021
  An overview of the key issues contained in the public consultation paper. The consultation is seeking feedback on options for improving the clarity and performance of the Code.

May 2021

• Quality Control of Biotechnological or Biological Medicines, 25 May 2021
  Manufacturing quality perspective
• EU Medical Device Regulation: Implications for the TGA and Australia, 18 May 2021
  EU Medical Device Regulation changes and the implications for the TGA and Australia.
• Good Manufacturing Practice (GMP) Forum 2021, Online, 12-14 May 2021
  Presentations given by the TGA at the GMP Forum 2021

March 2021

• Medicinal cannabis advertising compliance, 18 March 2021
  Advertising rules and responsibilities, including how they may affect the preparation of public facing communications and other activities.
• Special Access Scheme Portal, 11 March 2021
  Walkthrough changes to the SAS Category B forms and Authorised Application form.
• TGO 110: Standard for unapproved vaporiser nicotine products, 4 March 2021
  An overview of TGA's proposed safety and quality requirements for unapproved vaporiser nicotine products
• Medicinal cannabis advertising compliance, 3 March 2021
  Overview to assist industry and other interested parties to understand their obligations in regards to advertising medicinal cannabis.

Febuary 2021

• The regulation of medical device software, February 2021
  An overview of medical device software regulation in Australia.
• Australian Dental Industry Association (ADIA), 16 February 2021
  Overview of the new framework including regulatory concepts and worked examples for the dental industry
• Australian Orthotic Prosthetic Association (AOPA), 16 February 2021
  Overview of the new framework including regulatory terminology and worked examples
• Personalised Medical Devices Framework
  Guidance for industry on the new regulatory framework for personalised medical devices commencing on 25 February 2021.

November 2020

• Section 7 Declaration that certain sports supplements are Therapeutic Goods
  Help sponsors to understand the changes to the regulation of sports supplements arising from the recent declaration