New Zealand Device Industry Wary of New Joint Regulatory Agency

New Zealand consumers and health boards can expect increased healthcare costs and less access to innovative medical devices if the Australia New Zealand Therapeutic Products Agency (ANZTPA) is created as currently planned, according to the Medical Technology Association of New Zealand (MTANZ).

“We totally support the need for medical devices in New Zealand to meet internationally recognised standards for safety and performance. We do not, however, support the potentially unlimited cost of running the new joint regulatory agency being fully funded by industry and the agency duplicating pre-market approval or clearance for no additional benefit,” MTANZ Chief Executive Faye Sumner said.

The new agency will replace Australia’s Therapeutic Goods Administration and New Zealand’s Medical Devices Safety Authority.

While MTANZ supports the move, it is concerned the agency could create unnecessary costs. There currently are no regulatory costs for commercializing a medical device in New Zealand, according to the council.
Sumner said MTANZ has advocated internationally over the last few years for a globally harmonised regulatory system so companies do not have to meet multiple, and potentially conflicting, requirements or have to re-register devices in each country.

“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, and most especially for New Zealand consumers and taxpayers who will ultimately bear the increased costs of compliance,” she said. “We are looking to the joint regulator to demonstrate significant cost and compliance efficiencies in the new regulatory scheme.”

Companies that want to market a medical device in New Zealand must notify their devices with the country’s regulatory body, Medsafe, before placing the product on the local market. MTANZ proposes the emphasis be placed on improving post-market surveillance and utilizing globally-accepted medical device market clearances to maintain public health and safety.

In a discussion document ANZTPA recently released, MTANZ proposed five principles to guarantee timely access to safe medical technology while supporting industry innovation:

1. A regulatory scheme based on international best practice;
2. A regulatory scheme that recognises third-party conformity assessment for all classes of medical devices;
3. A regulatory scheme with a fee structure that is limited to efficiency costs only and fairly reflects the market size;
4. A regulatory scheme that has a major focus on post market vigilance and surveillance; and
5. A regulatory scheme that fosters and supports innovation and does not severely lengthen time to market.

“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,” the document reads. “Our growing manufacturing medical device sector earned export revenues of around $642m 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.”

“Under the proposed system some local manufacturers have said they may be forced to remove their device from the domestic market and only manufacture for export, making these innovative devices inaccessible for New Zealanders. “Regulation must be balanced with the need to create an operating environment that fosters and supports innovation and clinical benefit,” the document continues.

The ANZTPA regulations are expected to take effect by July 2016 if the two governments approve them.