Joint regulatory agency can assure safety

Media Release

June 20, 2011

Joint regulatory agency can assure safety

The Medical Technology Association of New Zealand (MTANZ) today said that having one regulator for both Australia and New Zealand to assure medical device safety can work for New Zealand if some of the issues raised previously are addressed this time.

“We welcome the opportunity to work with the Minister and Australia New Zealand Therapeutic Products Agency (ANZTPA) Transitional Agency to ensure a workable and viable process,” comments MTANZ chief executive Faye Sumner.

Ms Sumner says that over the past few years MTANZ has been advocating internationally for a globally harmonized regulatory system so that companies do not have to meet multiple, and potentially conflicting, requirements or having to re-register in each country.

“We do support medical devices placed on the New Zealand market being able to demonstrate that they meet a recognised international standard for safety and efficacy. While there will undoubtedly be benefits for companies who operate across both markets, we have some concerns for our New Zealand manufacturers and NZ-owned domestic companies.”

Currently, there are no regulatory costs for offering a medical device for sale in New Zealand.

MTANZ wants to ensure innovative, life-saving medical devices continue to be available for NZ. Under a proposed single-entry process the NZ-owned domestic companies could be disadvantaged by their market size relative to Australia. MTANZ believes they could bear an unfair cost burden.

“Our burgeoning manufacturing medical device sector earned export revenues of around $600m last year and we would not like to see these manufacturers distracted from their main focus of developing and servicing new markets to be tied up in this new regulatory process and any unreasonable costs.

Our NZ-manufactured devices are already audited to recognised international standards to enter offshore markets and we want to be assured that the ANZTPA process will not subject them to further costs and time for no tangible benefit.
“When ANZTPA was mooted before we realized that the Australian cost structure would provide compliance challenges for New Zealand companies so we are looking for improved engagement to ensure our concerns are respectfully heard and addressed to ensure New Zealanders continue to benefit from available innovation.
ENDS

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