The New Zealand Ministry of Health Medicines and Medical Device Safety Authority (MedSafe) unit oversees the country's medical device market. Your device must be listed in MedSafe's Web Assisted Notification of Devices (WAND) database within 30 days of a person or organization becoming the sponsor of the device and device market entry. Pre-market approvals of devices are not required by MedSafe, but manufacturers must provide proof of compliance with US, Canadian, EU or Australian medical device regulations in order to gain market entry in New Zealand.
Let Emergo assist you in evaluating the New Zealand medical device regulatory framework as it applies to your device(s)
Emergo's worldwide network of consultants as well as industry and regulatory sources enables us to provide incisive coverage of medical device markets including New Zealand.
Through our global network of in-house consultants, industry contacts and regulatory sources, Emergo provides in-depth coverage of multiple medical device markets, including New Zealand. Our Global Regulatory Overview reporting service for New Zealand covers:
- Regulatory Background for MedSafe
- Product Assessment
- Authorized Representation in New Zealand
- Medical Device Registration Requirements
- Costs and Timeframes
- Labeling and Language Requirements
- New Zealand Regulatory Roadmap
Please contact us for more information about our Regulatory Overview Report for New Zealand.