Phase 3 ANZTPA consultation documents released
24 April 2007
Please note: This consultation closed on 13 June 2007.
Phase 3 of the ANZTPA Stakeholder Consultation Programme 2006/07 began on 4 April 2007, with the release for stakeholder consultation of three draft Orders relating to medical devices. The first three draft Orders were published on the following webpage ANZTPA Orders which has been developed to provide a central resource for stakeholders looking for the technical details to be contained in Orders.
The following documents (which constitute two of the major elements of this third phase of the consultation) have been released for public consultation:
- In-Vitro Diagnostic Devices (IVD) Revision Draft of the proposed Australia New Zealand Therapeutic Products Regulatory Scheme (Medical Devices) Rule 2007
- Consultation Paper: The Regulation of Human Cellular and Tissue Therapies (HCTs)
The closing date for submissions on the IVD Revision Draft of the Medical Devices Rule and the Consultation Paper on HCTs was 13 June 2007.
In addition the following accompanying resource document is also available:
Consultation is crucial in ensuring the proposed regulatory scheme meets the overall objective of safeguarding public health and safety in both Australia and New Zealand.
Key stakeholder groups will be invited to focus group meetings which are expected to be held in Australia and New Zealand during May 2007.
Further information
In-Vitro Diagnostic Devices (IVD) Revision Draft of the proposed Australia New Zealand Therapeutic Products Regulatory Scheme (Medical Devices) Rule 2007
The IVD Revision of the draft Medical Devices Rule sets out the proposed arrangements for the regulation of IVDs under ANZTPA.
Under ANZTPA, it is proposed that IVDs will be regulated as a subset of medical devices, therefore the draft Rules relating to IVDs have been included in the draft of the Medical Devices Rule that was released for stakeholder consultation in May 2006. For ease of reference, the new sections relating to IVDs have been highlighted by surrounding the text in grey boxes. This document has been named the IVD Revision Draft and stakeholders are asked to restrict their comments to IVD aspects only.
Please note that the remainder of the draft Medical Devices Rule used to place the IVD components in context, for the purpose of stakeholder consultation, remains unchanged from the previous consulation draft. Changes resulting from stakeholder submissions received during the previous consultation period, on the draft Medical Devices Rule, have NOT been reflected in this version of the Rule. Once submissions have been analysed on the IVD components of the Rule, a final version of the Medical Devices Rule will be prepared incorporating all changes to the Rule which have been agreed between the Australian and New Zealand Governments.
Stakeholders should also be aware that the IVD Revision Draft of the Medical Devices Rule, only includes the regulatory proposals for "commercial" IVDs. The regulation of "in-house" IVDs (ie those manufactured by laboratories for use within that laboratory) are not included in the draft Rule. Further discussion will occur with stakeholders in Australia and New Zealand before a decision is made on whether to include in-house IVDs in the joint regulatory scheme for therapeutic products. When providing comments on the IVD Revision Draft of the Medical Devices Rule, stakeholders are asked to restrict their comments to the regulation of 'commercial' IVDs as detailed in the Rule.
In addition the following accompanying resource document is also available:
Consultation Paper: The Regulation of Human Cellular and Tissue Therapies (HCTs)
This Consultation Paper outlines the proposed arrangements to apply to human cellular and tissues therapies (HCTs) in the joint regulatory scheme for therapeutic products.
It is proposed that HCTs will be regulated under a Biologicals Rule and the submissions received on this consultation paper will help to inform the development of this Rule.
Consultation Paper: The Regulation of Human Cellular and Tissue Therapies (HCTs) (pdf,219kb)
Accompanying resource document for IVDs
The Plain English Guide for IVDs (pdf,206kb) is also available to provide context and assist readers' understanding of the key features of the regulatory proposal.
URL: http://www.anztpa.org/consult/consdocs3.htm