Conformity Assessment limitations to be removed for Australian manufacturers of medical devices

The following announcement was made in October by the Therapeutic Goods Administration: ‘New regulations will be introduced to allow Australian manufacturers to obtain market approval for most medical devices using conformity assessment certification from European notified bodies.’

Fiona Nash, The Assistant Minister for Health, announced that, under the Government’s Industry Innovation and Competitiveness Agenda, new regulations will be introduced to allow Australian manufacturers to obtain market approval for most medical devices using conformity assessment certification from European notified bodies.

This change will benefit Australian manufacturers by providing them with process flexibility and quicker market accessibility; which will benefit the public. The change will also assist in bringing Australian manufacturers in line with overseas medical device regulations and will stop the duplication of certification process to access the different markets.

Australian manufacturers will be able to choose having their conformity assessment conducted by the TGA or a European Notified Body.

The good news, however, does not apply to Australian manufacturers of Class III medical devices and Class 4 IVD’s. These devices will still need TGA conformity assessment.

The regulatory change is expected to take place later this year.

For assistance with your conformity assessment process contact KD&A on +61 4 11 101 392 or email us at kdent@kdas.com.au