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11 October 2021
- Webinar presentation: 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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