New Zealand Medical Device Regulations

Our regulatory consulting specialists support market access in the New Zealand medical device market.

Medicines Regulations 1984 and the Medicines Act 1981

New Zealand Medical Device Regulations

In New Zealand, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is the authority responsible for medical device safety & quality control, and vigilance. Medsafe regulates medical devices under the Medicines Regulations 1984 and the Medicines Act 1981. A streamlined regulatory process can be appealing to manufacturers seeking to enter the New Zealand Medical Device Regulations market.

New Zealand has a high standard of healthcare, and the demand for innovative and advanced medical technologies is present. Healthcare professionals in the country are often receptive to new technologies that can enhance patient care and outcomes. Market Access/New Zealand Medical Device Regulations.jpg?preset=content

Medical Device Classification in New Zealand

New Zealand Medical Device Regulations

All medical devices are classified following a risk-based approach comparable with the European Union and the FDA classification systems. The range spans from Class I (basic/sterile/measuring), IIa, IIb, and III, where Class I (basic/sterile/measuring) is low risk, and Class III is high risk.

The New Zealand healthcare system places a strong emphasis on quality and safety. Companies that can demonstrate their medical devices' high quality and safety standards will find acceptance in the market.

Registration routes in New Zealand

Registration process

All medical devices must be listed in Medsafe’s Web-Assisted Notification of Devices (WAND) database within 30 days of commercialization. Before the device can be listed in WAND, the manufacturer must ensure that they have the documentation that proves the device’s safety and effectiveness because Medsafe may request such information.

In New Zealand, there is no requirement for an extensive review process of registration documentation. Only a database registration and a declaration according to section 7 of the Medicines (Database of Medical Devices) Regulations 2003 are required to place the devices on the New Zealand market. Registration in Australia and New Zealand are often done simultaneously leveraging EU or US technical documentation.

Global regulatory strategy

New Zealand is known for its transparent and business-friendly environment. This can make it easier for companies to understand and navigate business regulations, fostering a favorable environment for market entry.

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Similar regulatory frameworks

We can help you navigate the regulatory landscape effectively and open doors for potential collaboration and market expansion. If your company plans to expand its market globally, having experience with and understanding regulatory processes, such as the New Zealand Medical Device Regulations, we can help you facilitate entry into other markets with similar regulatory frameworks. 

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Qserve services for New Zealand

  • Go-to-market strategy development
  • WAND database registration support
  • Sponsor support
  • Translations label and IFUs based on requirements


Representation for foreign manufacturers

Authorized Representative requirement

If a company does not have a physical establishment in New Zealand, it must appoint a local authorized representative, a so-called sponsor. The sponsor submits WAND applications and acts as the sole liaison between the manufacturer and Medsafe for any matters related to the product. The sponsor pays product-related fees (applications, annual costs, etc.). Like the Australian regulatory system, the New Zealand regulatory system requires the sponsor to be responsible for vigilance activities. This is one of the reasons why sponsors often offer a combined sponsorship for Australia and New Zealand.

Market Access

Harmonization between Australia and New Zealand

Australia and New Zealand have a Trans-Tasman Mutual Recognition Arrangement (TTMRA), which means that if a medical device is legally supplied in one country, it can be recognized and sold in the other without additional regulatory processes. This harmonization streamlines market access for manufacturers targeting both markets. 
However, it's important to note that the TTMRA applies to certain categories of medical devices and has specific conditions and requirements that need to be met for mutual recognition. The regulatory agencies responsible for therapeutic goods in each country (the TGA in Australia and Medsafe in New Zealand) have guidelines and processes to facilitate the mutual recognition of therapeutic goods under the TTMRA.


Do you need assistance registering in New Zealand or want to know more about New Zealand Medical Device Regulations? 

Qserve is your trusted partner for market access in New Zealand.

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Language requirements

How to communicate with the authorities?

English is the primary language in New Zealand, which can simplify communication and marketing efforts for companies whose primary language is English. This makes navigating regulatory processes easier, communicating with healthcare professionals, and marketing products effectively.

Small, Well-Defined Market

Reasons to enter the New Zealand medical device market

While New Zealand has a relatively small population, it provides a well-defined and manageable market. This can be advantageous for companies launching new products before expanding to larger markets. It has a collaborative healthcare ecosystem with strong ties between industry, academia, and healthcare providers. This can create opportunities for partnerships, research collaborations, and joint ventures.

Important links and guidance

Where to find more information?

  • The Web Assisted Notification of Devices (WAND) Database
    WAND database