Revised: 10 May 2011
The Medicines Regulations 1984 establish minimum requirements for labelling of medical devices in New Zealand. Medical devices are expected to be labelled in accordance with international best practice.
Regulation 12(4) of the Medicines Regulations 1984 sets out the requirements for the labelling of medical devices. The regulation states;
No person shall sell any medical device that does not bear the name of the manufacturer of the medical device or the name of the manufacturer's distributor in New Zealand
All medical devices must be clearly labelled with the name of the manufacturer or the name of the manufacturer's distributor (i.e. sponsor) in order to comply with the regulation.
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.
The Global Harmonisation Task Force (GHTF) is an organisation comprising key regulators and trade representatives that is working to develop guidelines for the international harmonisation of medical device regulatory practice. Among the guidance produced by the GHTF are recommendations for the labelling and instructions for use of medical devices (refer GHTF Study Group 1 final document, GHTF/SG1/N43:2005). Medsafe recommends that sponsors and manufacturers apply the guidance contained in this document when developing their labelling and instructions for use.