Medical Device Registration - New Zealand

R

Raymond12

#1
Hi all,

I was aondering if you could help on a few matters with regard to registering medical devices in New zealand.

First question is what is the major notified body and also does anyone know the estimated costs and timelines for all class medical devices.

Any help on this matter would be greatly appreciated

Thanks,
Ray
 
Elsmar Forum Sponsor
R

Raymond12

#3
Thanks,

I have looked on there website but cant seem to find time frames or estimated cost for registration of medical devices
 
A

Adele

#4
Hi - medical devices are not currently regulated (as in approved by the regulatory authority) in NZ.

However, there is a regulation which requires you to list your medical device within 30 days of commencing supply or export of a new medical device.

This database is called the NZ Web Assisted Notification of Devices (WAND). The website can be found here - http://www.medsafe.govt.nz/regulatory/wand.asp.

The database as a whole mimics the Australian DEAL database. And, in fact, until very recently you could clone applications between the 2 databases.

There is currently no cost associated with submitting an application to WAND. This is likely to change when registration becomes mandatory (no ETA on that!). All Medsafe do is check that you have filled the form out correctly, rather than assess and approve your notification.

You also require a Sponsor resident in NZ.

As for timeframes, from memory it should only be a couple of days. If you allow for a week, then it will be suffficient.

Regards,

Adele
 
B

Bassman84

#6
Ray, do you have a sponsor in New Zealand? How have you managed to work around that requirement?

Does anyone know how its possible to use a business address for two sponsors?
Thanks!
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#7
Ray hasn't logged in since 18th January 2012 and his email address is no longer valid so I have no way to get in touch with him.

Hopefully someone else here can help you.
 
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