New Zealand MEDSAFE Guide for Medical
New Zealand Market Access for Medical Approvals
Importing Medical Devices into New Zealand
All importers of medical devices - be they subsidiaries, agents, 'private label' suppliers, parallel importers, or direct importers - have obligations that must be met when supplying products in New Zealand.
Multiple importers of the same device
Where there is more than one importer of the same medical device each importer is required to notify that medical device to the WAND database. A WAND notification is specific to a particular combination of sponsor (importer) and device. It is not possible for one sponsor to "piggy-back" on another sponsor's notifications.
Records to be kept
Sponsors of medical devices are expected to maintain records of the supply of medical devices so that in the event of a recall or corrective action the importer is able to determine which customers have potentially been supplied with the affected product.
Sponsors should also have a written procedure describing how to conduct a recall action.
Guidance on the recall procedure is contained in the New Zealand Medicines and Medical Devices Recall Code (PDF 468 KB, 49 pages)
Medical Device Legislation
The Medicines Act 1981 and its Regulations control the supply of medical devices in New Zealand. However some medical devices may be impacted by other legislation and regulations which must also be complied with before the devices may be legally supplied. It is the supplier's responsibility to ensure that their products comply with all applicable legislation.
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.
REGULATORY AGENCY
- MEDSAFE, Ministry of Health
REGULATIONS
Under current legislation, ministerial consent is not required for the distribution of medical devices.
Medical devices are subject to the notification requirements set out in the Medicines (Database of Medical devices) Regulations 2003.
Manufacturers are required to enter details into the medical device database through Web Assisted Notification of Devices (WAND).
Diagnostic devices for in-vitro use are exempt from notification requirements.
All condoms and intra-uterine contraceptive devices distributed in New Zealand are required by law to comply with applicable standards.
GUIDELINES
- A local representative is required (also known as a sponsor) is required to make WAND notifications.
- WAND may be accessed from the MEDSAFE website.
- The notification of a device to the WAND database does not constitute approval or endorsement of the safety or efficacy of a medical device by MEDSAFE or any other regulatory body.
- Registration of medical devices is expected to become a legal requirement in the future under proposed legislation.
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