Changes to the Definition of Medicines

Changes to the Definition of Medicines and Medical Devices in New Zealand Effective from 1 July 2014

Working toward co-ordination with Australian Therapeutic Goods Administration (TGA) under the ANZTPA agency, the New Zealand regulatory authority Medsafe have revised and published changes to the definitions for Medicines and Medical devices under the Medicines Amendment Act 2013.

The revised definitions closely align with TGA definitions and enable products such as medicated dressings, pregnancy tests and contact lens solutions to be categorised as medical devices. In addition some medical equipment, such as ultrasonic therapy apparatus used by physiotherapists and irradiating apparatus, previously exempt are now categorised as medical devices and covered by the new definition.

From the 1 July 2014, products previously categorised as medicines will no longer require consent from Medsafe to supply in New Zealand.

All products meeting the new definition of a medical device are required under the Medicines (Database of Medical Devices) Regulations 2003 to be entered on the WAND (Web Based Notification Database) for Medical Devices within 30 days of supply into New Zealand and to meet Medical Device regulatory requirements for New Zealand sponsors.

Contact ACRA Regulatory Services to discuss how we can help with your New Zealand Medical Device WAND notifications and Australian Medical Device registrations
acraregulatory@bigpond.com

Useful links

Review the Medsafe policy change:
http://www.medsafe.govt.nz/Medicines/policy-statements/definition-of-med.asp

Medsafe’s updated definitions and guidance manufacturers is available on
http://www.medsafe.govt.nz/regulatory/categorisation-of-products.asp

Medical Devices Regulatory Requirements for Sponsors
http://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp