Information about changes to the TGA
The following pages are dedicated to helping explain the new regulatory system for medical devices in Australia that commenced on the 4th October 2002. The new system has been established by the Therapeutic Goods Act, 1989 (The Act) as amended by the Therapeutic Goods Amendment (Medical Devices) Bill, 2002 and the Therapeutic Goods (Medical Devices) Regulations, 2002.
Devices within the field of rehabilitation engineering and assistive technology are now covered by the new Therapeutic Goods Act (TGA) regulations, whereas they weren’t before. Since the regulations are new to our field, a ‘phase in period’ has been initiated. We are awaiting notification from the TGA as to when this period will expire.
The following link will take you directly to the TGA website:
On this website, you will find information such as:
- links to the legislation and other guidelines
- registration forms
- a link to the 'Australian Register of Therapeutic Goods' (ARTG)
- a link to DEAL – 'Device Electronic Application Lodgement'
- information on how to report a problem with a medical device.
NovitaTech continues to liaise with the TGA with regard to the impact of the regulations on the custom manufactured and general assistive technology sector. Questions with regard to failed equipment should be directed to the TGA Medical Devices group in the first instance.
This page last updated: 6 March 2009
URL for this page: http://www.novitatech.org.au/content.asp?p=508
