Revised Medical Device Definitions Implemented in New Zealand
New Zealand medical device and drug market authority Medsafe has updated its process for defining medical devices and pharmaceutical products as part of an ongoing merger with the Australian Therapeutic Goods Administration.
Based on the Medicines Amendment Act of 2013, the Medsafe definition changes are intended to align New Zealand's system more closely with those of other market regulators; Medsafe now distinguishes devices from drugs based on mode of action rather than physical form. The terms “therapeutic purpose,” “medicine” and “medical device” have all been amended as of July 1, 2014. The regulator has also provided new product categorization guidelines to reflect its updated definitions.
Impact for medical device firms registered in New Zealand
These amended definitions will impact some manufacturers whose products are currently registered as drugs or devices in New Zealand. Some products previously regulated as drugs will now be regulated as medical devices, and must be entered into Medsafe's Web Assisted Notification of Devices (WAND) database by August 11, 2014.
In addition, Medsafe has re-categorized two types of medical equipment—ultrasonic therapy apparatuses and irradiating apparatuses—as medical devices; these products were previously exempt from Medicines Act requirements.
Next steps for affected manufacturers and sponsors
Companies must examine their product lines to determine which (if any) now fall under Medsafe's revised medical device definition. Any products now considered medical devices by New Zealand regulators must be notified to WAND by the August 11 deadline.
Firms should also provide Medsafe with lists of products they believe now qualify as medical devices rather than drugs; the regulator will then determine whether companies' re-categorizations are warranted.
What about pending registration applications?
In cases where manufacturers and sponsors have already submitted market authorization applications to Medsafe for products that were considered medicinal products before July 1, the regulator will partially refund application fees for firms whose submissions have not yet been evaluated, but not for applicants whose evaluations have already begun.