Australia needs to sort out regulatory duplication: Cochlear

The leader of Australian bionic ear maker Cochlear has
said that removing regulatory duplication is critical for keeping manufacturers
like itself in Australia.

Speaking to The Australian Financial Review, CEO Chris
Roberts said that the federal government needed to push ahead with its commitment to reduce red tape. This included a proposal
to remove the necessity for Therapeutic Goods Administration approval on medical devices
if these had already been approved by a “trusted international standard” such
as CE (Europe) or FDA (USA) certification.

The proposal was announced by then-assistant secretary for deregulation Josh Frydenberg (now assistant treasurer) last October, as
part of the government’s Industry Innovation and Competitiveness Agenda.

Without the removal of the need for two sets of
approval, the competitiveness and potential success as exporters would decrease
for advanced manufacturers.

Roberts said TGA were “good people” but could be slow,
which has become more and more of an issue in developing countries which
Cochlear exports to where a “country of origin” approval is required.

“So we have dozens of countries like India,
for example, like China, where you need Australian government approval before
we can apply for approval over there,” he told The AFR.

“So suddenly, if the TGA is slow – forget
Australia. It means there are dozens of countries where we will be kept out of.

“And that’s a problem because you sit here and
say: ‘can we be a globally competitive manufacturer in Australia if these
issues aren’t sorted out?’.”

Image: Flickr/Peter Miller