TÜV SÜD is one of the largest EU Notified Body in the world. Regulatory authorities throughout the world recognise our extensive experience. Within the scope of its registration procedure, the TGA recognises CE marking by an EU Notified Body, like TÜV SÜD. Given this, in most cases, low-risk medical devices can be registered for the Australian market within only three months.
Class-III medical devices with integrated pharmaceutical or biological components do not benefit from CE-marking. Their registrations frequently take up to one year or longer as they require a time-consuming Level 2 Application Audit. However, certified by TÜV SÜD, manufacturers often succeed in the registration process. TÜV SÜD is recognised as an auditing organisation under the MDSAP. Participation in the MDSAP generally results in efficient approval procedures. Manufacturers of medical devices who want to place their products on the Australian markets benefit from efficient registration thanks to TÜV SÜD.