Published: 23 September 2016
Medical Devices
Labelling of Medical Devices
Instructions for Use (IFU)
Labelling of Medical Devices
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.
Regulatory requirements
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.
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.
Information about medical device clinical trials
International guidelines
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.
Instructions for Use (IFU)
All medical devices are expected to be supplied with appropriate instructions for use (IFU). Medsafe recognises the trend towards supply of instructions for use in electronic formats and has guidance regarding electronic IFU.
Regulatory requirements
There are no specific legislative or regulatory requirements for IFU for medical devices under the Medicines Act 1981 or Medicines Regulations 1984. Medsafe recommends that sponsors and manufacturers follow international best practice when preparing IFU
Contraceptive products must include IFU as specified in the relevant approved Standard for that product type. Failure to do so would be a breach of the Contraception, Sterilisation and Abortion Act 1977.
See also Contraceptive Devices
International guidance
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.
Medsafe guidance regarding electronic IFU
Medsafe recognises that some countries permit the supply of IFU for medical devices in electronic formats as an alternative to hardcopy IFU supplied with the device. Electronic IFU can take several formats including; files supplied with the device on read-only media, files downloadable from the internet, and help files displayed by the device. Electronic IFU may be supplied in New Zealand but the sponsor must be able to provide upon request from a user a hardcopy of the IFU.
