Medical devices
- Draft Order: Medical Device Standards for Medical Devices Required to be Sterile
6 June 2007 - Draft Order: Conformity Assessment Standard for Quality Management Systems and Quality Assurance Techniques for the Manufacture of Medical Devices
6 June 2007 - Questions and answers about In-Vitro Diagnostic Medical Devices (IVDs) as included in the draft Medical Devices Rule
18 May 2007 - In-Vitro Diagnostic Devices (IVD) Revision Draft of the proposed Australia New Zealand Therapeutic Products Regulatory Scheme (Medical Devices) Rule 2007
24 April 2007 - Draft Order: Medical Device Standards for Clinical Evidence
24 April 2007 - Draft Order: Medical Device Standards for Risk Management
24 April 2007 - Draft Order: Conformity Assessment Standards for Quality Assurance Techniques for Animal Tissues and their Derivatives Utilised in the Manufacture of Medical Devices
24 April 2007 - Questions & answers about regulating medical devices
16 October 2006 - Consultation documents released (23 May 2006)
- Draft Medical Devices Rule
- Draft guideline on transition provisions for product licensing
- Draft Administration Rule
- Proposed fees and charges
- Transition to the joint regulatory scheme for medical devices
- Web assisted notification of devices (WAND)