Single use devices

The transition period for the implementation of the regulatory framework for the re-manufacture of single use medical devices (SUDs) ends on 1 December 2005. This means that by 1 December 2005 facilities planning to continue re-manufacturing SUDs need to have:

• undergone Conformity Assessment by the Therapeutic Goods Administration (TGA);
• obtained a TGA Conformity Assessment Certificate; and
• included the remanufactured SUDs on the Australian Register of Therapeutic Goods (ARTG).

It is recommended that re-manufacturers intending to apply for a Conformity Assessment Certificate submit their application to the TGA by 30 June 2005. Applications need to be submitted electronically through the Device Electronic Application Lodgement (DEAL). Once the application is received, a supplementary application form will be sent out.

For information and instructions on how to establish an E-business account with the TGA and to lodge an electronic application, please visit the TGA online services website <https://www.ebs.tga.gov.au>.

It is also recommended that you contact Mr Rod Ferrari in the Medical Devices Assessment Section for further assistance in relation to the conformity assessment application. Mr Ferrari can be contacted on 02 6232 8706.

The TGA has published a fact sheet Guidance regarding the remanufacturing of single use medical devices for reuse <http://www.tga.gov.au/devices/fs_sud.htm> to address a number of inquiries, relating to the regulatory framework and how it will impact on:

• devices labelled as 'Single Patient Use'
• people who re-manufacture SUDs for their own personal use
• specific devices such as single use or single patient use nebulisers and asthma spacers that may be used for multiple people in the community.

Medical devices fact sheets

Three new draft medical devices fact sheets are available:

• Differences between the Australian and European Union regulatory systems (1) - Fundamental differences and classification <http://www.tga.gov.au/devices/fs-aeu-class.htm>
• Differences between the Australian and European Union regulatory systems (2) - Essential principles <http://www.tga.gov.au/devices/fs-aeu-ep.htm>
• Re-manufacturing single use medical devices <http://www.tga.gov.au/devices/fs-sudman.htm>