Update on the ANZTPA Establishment Project
6 June 2007
This email was sent to ANZTPA-UPDATE email list subscribers on 6 June 2007.
Dear Sir/Madam
Recent updates to the Australia New Zealand Therapeutic Products Authority (ANZTPA) Project website are listed below:
The following draft Orders have been published for stakeholder consultation on the ANZTPA Orders web page <http://www.anztpa.org/consult/orders.htm> (consultation period closes 13 July 2007):
- Draft Order: Conformity Assessment Standard for Quality Management Systems and Quality Assurance Techniques for the Manufacture of Medical Devices (CASO 1) <http://www.anztpa.org/consult/orders/drcaso-manuf.htm>
- Draft Order: Medical Device Standards for Medical Devices Required to be Sterile (MDSO 3) <http://www.anztpa.org/consult/orders/drmdso-sterile.htm>
- Draft Order: Packaging Requirements for Specified Therapeutic Products <http://www.anztpa.org/consult/orders/drpackaging.htm>
In addition, outcomes from the third meeting of the Joint Interim Expert Advisory Committee on Standards (JIEACS) and the third & fourth meetings of the pharmacopoeial subcommittee of the JIEACS have been published for information at: Joint Interim Expert Advisory Committee on Standards <http://www.anztpa.org/committees/jieacs.htm>
Note: The project team would also like to remind stakeholders that submissions on the IVD and HCT consultation documents (published at Phase 3 ANZTPA consultation documents released <http://www.anztpa.org/consult/consdocs3.htm> close Wednesday 13 June 2007).