Presentations from the May 2007 ANZTPA targeted focus group workshops
May 2007
Following the release on 24 April 2007 of consultation documents relating to In-Vitro Diagnostic Devices (IVDs) and the Regulation of Human Cellular and Tissue Therapies (HCTs), targeted focus group workshops were held with industry associations and other key stakeholders.
The workshops, held in Australia and New Zealand during the first two weeks of May 2007, were attended by over 150 stakeholders as part of the ongoing ANZTPA Stakeholder Consultation Programme 2006/07 <http://www.anztpa.org/consult/programme0607.htm>.
Copies of the presentations from the IVD and HCT workshops can be downloaded below.
- Presentation – Proposed regulation of In-Vitro Diagnostic Medical Devices (IVDs) (pdf,167kb)
- Presentation – Proposed Regulation of Human Cellular and Tissue Therapies (HCTs) under ANZTPA (pdf,191kb)
Note: These presentations are made available for information only. The content should not be taken out of context, or be considered to represent every aspect of the regulatory proposals for IVDs and HCTs. To avoid misunderstanding, the presentations should be read in combination with the IVD and HCT consultation documents.
Questions and answers (Q&As) raised during the consultation workshops have been prepared and are available from the links below:
- Questions and answers about In-Vitro Diagnostic Medical Devices (IVDs) as included in the draft Medical Devices Rule
- Questions and answers about the Regulation of Human Cellular and Tissue Therapies (HCTs) under ANZTPA
These documents have been made available to provide an overview of the documents being considered and to assist stakeholders to prepare written submissions.
URL: http://www.anztpa.org/consult/0705pres.htm