TGA News Issue 44 (July 2004) - Medical devices
Note: The information in this issue of TGA News may no longer be current. Please check with the TGA before relying on the information on these web pages.
Device electronic application lodgement
Frequently asked questions and answers on the Australian medical devices legislation and the Device Electronic Application Lodgement (DEAL) <http://www.tga.gov.au/devices/dealfaq.htm> are now available.
Single use medical devices
The regulation of the re-manufacture of single use medical devices (SUDs) was implemented in December 2003 with a two-year transition period. This means that any facility wishing to re-manufacture medical devices labelled as "single use" or "single patient use" will need to comply with the regulatory requirements for a manufacturer of medical devices as described in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002.
- Regulation of the re-manufacture of single use medical devices (SUDs) <http://www.tga.gov.au/devices/sudreg.htm>
- FAQ on regulation of the re-manufacture of single use medical devices (SUDs) <http://www.tga.gov.au/devices/sudfaq.htm>
TGO 34A
A draft of TGO 34A Standard for diagnostic goods of human origin is available for comment. TGO 34A revises the scope of TGO 34 to include ex vivo diagnostics that contain materials of human origin and amends TGO 34 to include updated technical requirements, current practices and test methods. The consultation period for the draft document closes on 23 July 2004.