TGA News Issue 52 (March 2007) - Medical devices
October 2007 transition
The transition deadline of 4 October 2007 is drawing closer. In order for products to remain on the ARTG after this date, it is imperative that applications are lodged with the TGA before the following deadlines:
- Conformity assessment applications: 1 April 2007
- Application Audits: 1 June 2007
- Applications through DEAL & Manufacturers Evidence: 1 July 2007
In vitro devices
Two new guidance documents are available:
- Acceptable evidence of good manufacturing practice (GMP) for IVDs <http://www.tga.gov.au/devices/ivd-evidence.htm>
This document describes the process for submitting evidence of GMP to the TGA and applies to IVDs manufactured both within Australia and overseas. - The regulation of nutrigenetic tests in Australia <http://www.tga.gov.au/devices/ivd-nutrigenetic.htm>
This document describes what nutrigenetics is and the the current and future regulatory framework for nutrigenetic tests.
More information on the current and forthcoming regulation of IVDs <http://www.tga.gov.au/othertg/index.htm>.
Reasons for rejection of applications
The TGA notes that the rate of rejection or lapsing of applications to include medical devices in the Australian Register of Therapeutic Goods (ARTG) remains at approximately 20% and has not dropped significantly in the 4 years of operation of the new regulatory scheme.
We have therefore developed a list of reasons for rejection in order that sponsors may consider their readiness prior to submitting an application. See: Reasons for rejection of applications <http://www.tga.gov.au/devices/rejection.htm>