IVDs

In May 2004, the TGA consulted on a proposal to revise the scope of TGO 34 Standard for Diagnostic Goods of Human Origin to include ex vivo diagnostics and also to amend the order to include updated technical requirements, current practices and test methods.

Since then the TGA has progressed the development of two new regulatory frameworks:

1. the regulation of in vitro diagnostic (IVD) medical devices, and
2. the regulation of human tissues and cellular therapies, which will include ex vivo reagents.

The proposed introduction for new legislative requirements for both groups of products is 1 July 2005.

Following further consideration of the mechanisms of these new frameworks for IVDs and human tissues and cellular therapies in ensuring the quality, safety and performance of these products, the TGA has decided not to proceed with the proposed revision of TGO 34.

Medical device/medicine "boundary" products

Therapeutic Goods (Articles that are not Medical Devices) Order No. 1 of 2004 <http://www.tga.gov.au/legis/tgdev0401.htm>, gazetted in April 2004, implements changes to the way the TGA regulates antiseptic wipes, irrigation solutions, haemodialysis solutions and IVF media.

Australian Medical Devices Guidance Document No. 35 Device - Medicine Distinction <http://www.tga.gov.au/docs/html/devguid35.htm> also provides information on the status of boundary products for ARTG purposes.

Medical devices essential principles

It is the manufacturer's responsibility to demonstrate compliance with the essential principles for their medical devices. A medical devices essential principles checklist <http://www.tga.gov.au/devices/epcheck.htm> is now available.

Medical devices fact sheets

Five new medical devices fact sheets are available.

• Class 1 medical devices <http://www.tga.gov.au/devices/fs_class1.htm>
• Manufacturers of Class 1 medical devices <http://www.tga.gov.au/devices/fs_class1man.htm>
• Using GMDN codes <http://www.tga.gov.au/devices/fs_gmdn.htm>
• Suspension & cancellation of medical devices (draft for comment)
• Offences/enforcement/illegal supply of medical devices (draft for comment) <http://www.tga.gov.au/devices/fs-offences.htm>

Reusable medical devices

Reducing the Public Health Risks Associated With Reusable Medical Devices <http://www.tga.gov.au/devices/reusdev_phr.htm> discusses the issues and provides recommendations on strategies health care facilities and health authorities could adopt to improve the cleanability of reusable medical devices.