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NZ Regs Shake-up – what will become of medical devices?

The New Zealand Ministry of Health has announced that they are developing a new regime for the regulation of therapeutic products.

Following the cessation of the Australia New Zealand Therapeutic Products Agency (ANZTPA), the New Zealand Ministry of Health is looking to develop new therapeutic product legislation. The new legislation will encompass cell and tissue therapies and medical devices, which are currently not fully regulated in New Zealand. The new regime, promised to be highly effective and flexible, is expected to modernise and internationally align the regulation of therapeutic products in New Zealand.

Used under licence from Shutterstock.com

Used under licence from Shutterstock.com

Medical devices currently marketed in New Zealand do not undergo pre-market assessment. Instead, details of each medical device/sponsor combination are entered into the Web Assisted Notification of Devices (WAND) database within 30 days of commercialisation. As part of the new regulatory regime it is expected that the New Zealand legislation will align with the International Medical Device Regulatory forum (IMDRF) framework resulting in the risk based assessment of medical devices prior to supply.

The new legislation will replace the existing Medicines Act 1981 and is expected to be introduced into parliament in 2016. The impact of this new legislation on the pharmaceutical and medical device industry will become clearer as details of the new therapeutic products regime are published.

Once established, it is expected that an appropriate transition period will follow, however as yet the process and timing is not yet fixed. 

Commercial Eyes has extensive experience working with devices in several of the IMDRF harmonised regions and can be of assistance during this transition process in New Zealand when the time is right. Call us on +61 3 9251 0777.

This article was written by Megan Polidano from our Regulatory Services team.

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