Level playing field for Australian medical device manufacturers
Amendments to the Therapeutic Goods Act to remove the requirement for Australian manufacturers to submit conformity assessment direct to the TGA and to allow them to achieve Australian device registration based on CE certification alone is expected to be passed through Australia parliament by the end of the year.
The Australian domestic medical device manufacturers will be able to obtain market approval for most medical devices using conformity assessment certification from European notified bodies in line with the regulations for overseas manufacturers.
TGA Conformity Assessment will remain a requirement for high risk medical devices containing medicines or tissues of animal, biological or microbial origin, or Class 4 in vitro diagnostics (IVDs).
Click the link below to read the TGA news article:
Australian manufacturers of medical devices given a level playing field
Media release, Senator the Hon Fiona Nash – Assistant Minister for Health