Medical device makers down under are concerned about a government plan to create a new joint regulatory agency for medical devices in Australia and New Zealand.
This week, the governments announced a five year plan to create the Australia New Zealand Therapeutic Products Agency (ANZTPA), which will regulate medicines, medical devices and new medical interventions.
“New Zealand’s regulatory arrangements for medicines and medical devices need to be updated, and this is a cost-effective and comprehensive way of achieving this,” New Zealand Prime Minister John Key said in a government release. “We want to move into a situation where all medicines and medical devices are specifically approved for New Zealanders before they are used. Currently, medicines are subject to this approval but medical devices are listed on a notification database which should be improved – the establishment of this new agency provides the opportunity to do so.”
“We want to build the capability to ensure new medical technologies are safe to use, and are used safely, in New Zealand,” Key added.
The new agency will replace Australia’s Therapeutic Goods Administration and New Zealand’s Medical Devices Safety Authority.
The Medical Technology Association of New Zealand said it supported the move but was concerned that the agency could create unnecessary costs. Currently, there are no regulatory costs for offering a medical device for sale in New Zealand, according to the council.
The government did not go into detail as to how the new regulatory body would affect imports of medical devices. Currently, the Australian Therapeutic Goods Administration mirrors the European CE Marking system, according to the Emergo Group, a global regulatory consulting firm.
