TGA News Issue 48 (November 2005) - Medical devices
Note: The information in this issue of TGA News may no longer be current. Please check with the TGA before relying on the information on these web pages.
Conformity assessment
Conformity Assessment Standards Order No. 1 of 2005 - Replacement of Conformity Assessment Standards Order No. 1: Conformity Assessment Standard for Quality Management Systems and Quality Assurance Techniques revokes and replaces Conformity Assessment Standards Order No. 1 of 2003.
CASO 1 of 2005 introduces new conformity assessment standards for quality management systems for the manufacture of medical devices that require conformity assessment.
Disinfectants
Beginning in July 2005, comments were sought on proposed changes to the way the TGA regulates hospital, household and commercial grade disinfectant products <http://www.tga.gov.au/consult/2005/disinfectants.htm>.
The consultation period closed on 30 September 2005 and responses are under consideration. The document is still available.