New Regulations Introduced for Australian Medical Device Manufacturers

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.
The regulations were announced by  the Assistant Minister for Health, Fiona Nash, under the Government’s Industry Innovation and Competitiveness Agenda.
“With these changes, Australian manufacturers can choose to either have conformity assessment conducted by the TGA or an alternative conformity assessment body, such as a European notified body," Minister Nash said.
“This will cut red tape, provide more flexibility for local medical device manufacturers and, in many cases, enable devices to get to market more quickly, which will benefit the public.”
Minister Nash said the new arrangements would bring Australian manufacturers in line with the regulations for overseas manufacturers.
"The new rules will not, however, apply to the very highest risk devices. These devices will still need TGA conformity assessment. These include devices containing medicines or tissues of animal, biological or microbial origin, or Class 4 in vitro diagnostics (IVDs), for example, drug-eluting stents or tests for HIV respectively," she said.
Once the new regulations are implemented, Minister Nash said applications for lower risk Class II and Class III medical devices and IVDs, like Australian-made hearing aids, joint implants, and devices used for in-vitro fertilisation procedures, would be able to rely on conformity assessment certification from European notified bodies.
“Less red tape means Australian medical device manufacturers will no longer have to duplicate conformity assessments if they want to supply their device in the European and Australian markets,” Minister Nash said.
Regulatory amendments to implement this change are being prepared, and are expected to be in place later this year. This will require amendments to the Therapeutic Goods (Medical Devices) Regulations 2002