Update: Increased application audit requirements for some medical devices applications

6 June 2018

In September 2014, the TGA responded to concerns outlined in a British Medical Journal article (BMJ 2012; 345: e7126) which questioned the reliability of eight European Notified Bodies. Following consideration of the article and consultation with other regulators, the TGA had decided to select for audit all applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG) that used supporting evidence from the named notified bodies.

The TGA has continued to monitor this matter, including through our regular joint sectoral meetings with the EU Commission. As a result of the added scrutiny of notified bodies that has recently occurred in Europe, including the joint assessment process that resulted in de-designation and redefining the designations of some notified bodies, the TGA no longer considers it necessary to apply these increased audit requirements.

Further information

Please contact devices@tga.gov.au if you require further information.