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Automatic conditions for medical devices - legislative amendments
Legislative amendments have been made to improve transparency and clarity in relation to the standard conditions applied to all ARTG inclusions for medical devices. These conditions relate to storage and transport, record keeping, annual reporting and notification of information relating to certain IVD medical devices.
Do sponsors need to do anything?
These changes do not require sponsors of medical devices to do anything new in addition to what they have already been asked to comply with.
An administrative review of the standard conditions commonly applied across all medical devices indicated that the text of some of these conditions may be difficult to follow and/or language used is out of date, and some conditions are no longer relevant.
Also, we noted that making changes to existing ARTG entries to update these conditions individually is technically and administratively difficult, and is time and resource consuming.
The decision to include these conditions in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002, and make them apply automatically, ensures transparency and consistency across all medical devices included in the ARTG. Also, this change brings the imposition of standard conditions for medical devices into line with the situation for registered or listed goods.
Any substantive updates to automatic conditions require legislative amendments, and therefore would be subject to normal consultation requirements prior to any amendment.
What will be different?
As soon as practicable, all information appearing on ARTG certificates presently under the title 'Standard Conditions' will be removed, as the conditions now apply automatically.
Some of the existing 'Standard Conditions' relating to the identification of sponsors and customs requirements do not appear in the regulations, as these requirements are covered elsewhere.
There have been no changes made in relation to specific conditions individually imposed on some ARTG entries.
Automatic Conditions applying under the regulations
The conditions are set out Part 5, Division 5.2 (5.9 to 5.12) of the Therapeutic Goods (Medical Devices) Regulations 2002.