Labelling and Instructions for Use Requirements for Medical Devices in New Zealand

1. Legal Basis

The labelling of medical devices in New Zealand is governed by Regulation 12(4) of the Medicines Regulations 1984, which requires that 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. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp All medical devices must be clearly labelled with the name of the manufacturer or the manufacturer's distributor (sponsor) to comply. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp

There are no specific legislative or regulatory requirements for instructions for use (IFU) for medical devices under the Medicines Act 1981 or Medicines Regulations 1984. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp However, contraceptive products must include IFU as specified in the relevant approved Standard for that product type, and failure to do so would be a breach of the Contraception, Sterilisation and Abortion Act 1977. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp

2. Essential Principles

Medical devices are expected to be labelled in accordance with international best practice. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp Medsafe recommends that sponsors and manufacturers apply the guidance contained in the Global Harmonisation Task Force (GHTF) Study Group 1 final document, GHTF/SG1/N43:2005, for labelling and instructions for use. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp

For clinical trials, Medsafe recommends that any medical device 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. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp

All medical devices are expected to be supplied with appropriate instructions for use (IFU), following international best practice. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp

3. Detailed Labelling Elements

Mandatory labelling includes the name of the manufacturer or the manufacturer's distributor (sponsor). https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp

4. IFU Specifics

IFU must be supplied appropriately with all medical devices. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp Medsafe recognises the trend towards electronic formats for IFU and permits their supply in New Zealand, including files supplied with the device on read-only media, files downloadable from the internet, and help files displayed by the device. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp However, the sponsor must be able to provide a hardcopy of the IFU upon request from a user. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp

For contraceptive products, IFU must comply with the relevant approved Standard. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp

5. Additional Notes

The GHTF guidance (GHTF/SG1/N43:2005) is recommended for both labelling and IFU development. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp

No specific requirements for different device classes (e.g., active, implantable, IVD, custom-made), exemptions, or language requirements are detailed in the content. https://www.medsafe.govt.nz/Devices/labelling-and-ifu.asp