Medicines Regulations 1984 and the Medicines Act 1981
New Zealand Medical Device Registration
Entering the New Zealand medical device market requires compliance with the country’s regulatory framework, overseen by Medsafe (the New Zealand Medicines and Medical Devices Safety Authority). All medical devices must be registered in the Web-Assisted Notification of Devices (WAND) database. This registration process ensures that Medsafe records all medical devices supplied in New Zealand, promoting safety and transparency in the healthcare market.
One advantage of entering the New Zealand market is its alignment with Australia’s TGA approval process. Medsafe accepts TGA-approved devices, which significantly simplifies registration for manufacturers already approved in Australia. This streamlined process makes New Zealand attractive for expanding its global medical device market presence.
Qserve supports you in navigating the registration process, ensuring that your device meets all requirements for inclusion in the WAND system. From preparing the necessary documentation to guiding you through compliance with Medsafe’s regulations, we ensure a smooth and efficient entry into the New Zealand market.
Regulatory Compliance in New Zealand
How Qserve Supports You
Entering the New Zealand medical device market can be a strategic move for manufacturers looking to expand their global presence. At Qserve, we provide tailored support to simplify the New Zealand Medical Device Registration process, ensuring a smooth path to market entry. This is how Qserve supports you:
- Strategic Planning
We work with you to develop a tailored strategy, considering the advantages of leveraging existing overseas approvals.
- Expert Guidance on WAND Registration
Our expertise ensures that your device meets all Medsafe compliance requirements.
- Global Network of Partners
With a strong network of global partners and close collaboration with sponsors in New Zealand and Australia, Qserve provides seamless regulatory support.
- Proven Experience
Our team has hands-on experience with New Zealand Medical Device Registration and understands the regulatory landscape.
By partnering with Qserve, you gain the advantage of expert guidance and proven strategies to succeed in the New Zealand healthcare market.
Please contact us for more information on how Qserve can assist with your New Zealand Medical Device Registration.