Shipping Investigational-Use Only Devices to New Zealand

J

jennaleeb

#1
Hello there!

We are shipping medical devices to be used in a focus group (clinical trial I suppose you could call it) at a university in New Zealand and I want to make sure it does not get caught in customs as it is not an approved medical device.

Is there any special labelling that needs to go on the shipping container or in the customs documentation?

I appreciate any insight anybody has!

Jenna
 
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sreenu927

Quite Involved in Discussions
#2
There is no specific medical device regulation in New Zealand for such devices; however, they closely follow and accept Australian TGA regulations. Also you may use EU or US FDa regulations for labelling such medical devices meant for investigation or clinical trials.

Regards,
Sreenu
 

Ronen E

Problem Solver
Staff member
Moderator
#3
http://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp:

Medsafe does not regulate or approve clinical trials for medical devices in New Zealand, but does request that it be informed of such trials. [...] Medical device clinical trials require ethics committee approval and are expected to be conducted in accordance with international best practice guidelines.
http://www.medsafe.govt.nz/regulatory/DevicesNew/10Labelling.asp:

Clinical Trials

Medsafe recommends that any medical device that is supplied for the purpose of a clinical trial is clearly labelled as being for clinical trial use only and should also be labelled with the reference number of the clinical trial.
 
#5
You might want to include a zero dollar proforma invoice stating that they are samples and of no value. That way Customs will be less likely to charge import tax.
 
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