Articles that are not medical devices

In Therapeutic Goods (Articles that are not Medical Devices) Order No. 2 of 2004 <http://www.tga.gov.au/legis/tgdev0402.htm>, gazetted in December 2004, the following class of articles are declared not to be medical devices:

"Topical applications intended to remove or neutralise chemical, biological or radiological agents used in chemical, biological or radiological warfare."

Canada/Australia MOU

The Health Products and Food Branch, Health Canada, and the TGA held meetings in January, February and April 2005 to work out the details on a Memorandum of Understanding regarding the reciprocal recognition of quality system certificates issued for manufacturers of medical devices.

It is expected that the MOU will be in place prior to the commencement of the Australia and New Zealand Trans Tasman therapeutic products agency in July 2006. Further details on the nature, scope and proposed implementation of the MOU and on plans to engage stakeholders will be communicated as the project progresses.

For more information see: MOU between the Canadian Health Products & Food Branch and the TGA for medical devices <http://www.tga.gov.au/international/moudev_canada.htm>

MDEC update

The report and summary of key resolutions <http://www.tga.gov.au/docs/html/mdec/mdec20051.htm> from the March 2005 Medical Device Evaluation Committee meeting are available.

Medical devices fact sheets

Three of the Australian medical devices fact sheets have been updated and one has been finalised since the last issue of TGA News.

• Class 1 medical devices (updated) <http://www.tga.gov.au/devices/fs_class1.htm>
• Manufacturers of Class 1 medical devices (updated) <http://www.tga.gov.au/devices/fs_class1man.htm>
• The use of GMDN codes according to the Australian regulatory system (updated) <http://www.tga.gov.au/devices/fs_gmdn.htm>
• Suspension & cancellation of a medical device entry in the Australian Register of Therapeutic Goods (ARTG) (finalised) <http://www.tga.gov.au/devices/fs_suspcanc.htm>