Registering Medical Devices in Australia and New Zealand - ANZTPA

#1
Hi,

Firstly I want to thank everybody for the wealth of information I've gathered from this forum over the past 6 weeks or so - it's been so helpful. I've never needed to sign up and start my own post until now because everything has been covered ... but I'd like some help with the below please!

I have recently moved from a MD company where I managed an RA team responsible for registering all products in LATAM, EMEA (excluding EU), and some of SE Asia, to an IVD company where I am registering the products globally myself.

At the MD company, we had a dedicated member of staff based in Australia who basically told us that anything that was registered in Australia with the TGA was essentially approved in neighbouring New Zealand and didn't need any further work other than securing TGA approval.

Having done some research, it seems like the ANZTPA efforts were ceased in 2014. Can somebody please help with some guidelines on registering products in New Zealand and what the process is there?

Many thanks!
 
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