Revised Medical Device Definitions Implemented in New Zealand – Effective 1 July 2014

In preparation for the merge of the Australian Therapeutic Goods Administration (TGA) and New Zealand (NZ) Medsafe, Medsafe have published a change the existing process for defining medical devices and pharmaceuticals in NZ.

Medsafe has released the Medicines Amendment Act of 2013 which alters the existing Medsafe system to align more closely with Australia’s framework for determination and classification from 1 July 2014. As part of this change, Medsafe have developed product categorisation guidelines to reflect the updated definitions and guidance manufacturers. 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. In addition, Medsafe has re-categorised two types of medical equipment—ultrasonic therapy apparatuses and irradiating apparatuses—as medical devices; these products were previously exempt from Medicines Act requirements.

The newly released changes will affect some manufacturers whose products were considered to be drugs, however are now deemed to be devices. In this case, manufacturers should enter their devices into the Web Assisted Notification of Devices (WAND) database by August 11, 2014. Medsafe have also advised that manufacturers who require assistance in determining the product classification within the amended framework should contact them.

Manufacturers that have market authorisation applications in process for drugs – which will now be deemed medical devices, Medsafe have advised that they will partially refund application fees for companies whose submissions have not yet been evaluation, but not for the submissions for which evaluation has begun.

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