by Anne, Consultant on RegDesk –
Effective from 1 July 2014
Working toward co-ordination with the Australian Therapeutic Goods Administration (TGA) under the ANZTPA agency, the New Zealand regulatory authority Medsafe has 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 categorized as medical devices. In addition some medical equipment, such as ultrasonic therapy apparatus used by physiotherapists and irradiating apparatus, previously exempt are now categorized as medical devices and covered by the new definition.
From the 1 July 2014, products previously categorized as medicines will no longer require consent from Medsafe to supply in New Zealand. Medical device regulations changed.
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.
I can help with your New Zealand Medical Device regulations and WAND notifications and Australian Medical Device registrations
Useful links
Review the Medsafe policy change
Medsafe’s updated definitions and guidance manufacturers
Medical Devices Regulatory Requirements for Sponsors
