In Short
- You must have a New Zealand-based sponsor to sell medical
devices.
- All medical devices must comply with safety and
record-keeping requirements.
- The Consumer Guarantees Act ensures devices meet quality
and performance standards.
Tips for Businesses
Ensure your medical devices comply with all New Zealand
regulations, including having a sponsor and maintaining accurate
records. Be aware of consumer protection laws to avoid costly legal
issues, as failing to meet standards can result in repairs,
refunds, or replacements.
If you manufacture or distribute medical devices and are looking
to enter the New Zealand market, there are several important legal
requirements you need to be aware of. NZ has specific regulations around the importation,
sponsorship, notification and advertising of medical devices,
which act to protect consumers. This article will outline the key
points businesses should know before selling medical devices in New
Zealand.
