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.
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.
GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
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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