Regulatory decisions & notices
31 August 2012
- Reclassification of hip, knee and shoulder joint replacement implants: transition period to 30 June 2014
Implantable medical devices intended by the manufacturer to be a hip, knee or shoulder joint replacement implant (total or partial) are to be classified as Class III medical devices from 1 July 2012 - Medical device amendments to the EU-Australia MRA on conformity assessment to come into effect 1 January 2013
Amendments to the EU-Australia MRA (Mutual Recognition Agreements) on conformity assessment to come into force on 1 January 2013 - Regulation impact statements for medical devices
Links to regulation impact statements for medical devices - Performance evaluation & assessment of technical information of IVDs
The TGA has finalised a two stage tender process for the provision of expertise and services for the assessment of technical information and performance evaluation of IVDs - Changes to the medical device application form for inclusions
The Medical device application form in eBS has been updated to include additional questions to allow applicant's the opportunity to notify relevant Health Technology Assessment secretariats of their intent to apply for HTA reimbursement of their product - IVD medical devices regulations update, March 2010
On 25 February 2010 the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were made by the Governor-General
Web page last updated: Wednesday, 31 October 2012
URL: http://www.tga.gov.au/industry/devices-decisions.htm