Things You Should Know About Medical Device Registration in New Zealand
Share
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.
All medical devices in New Zealand must be listed in Medsafe’s Web-Assisted
Notification of Devices (WAND) database. Prior to the Device being able to be
listed on the WAND database, the Sponsor MUST be able to provide to
Medsafe documentation that proves the device’s safety and effectiveness –
This means that the medical device is proven safe and does what it is claimed
to do.
OUR Medical Devices are all listed in the WAND, and have European Union
approval and certification, so with our devices, you know they are safe. You
know that they will do, what they were intended to do – This means you and
your patients, can rely on the claims made.
You can be assured of our responsibility towards continued safety and
effectiveness – A standard achieved by our devices, and continued on-going, a
requirement of the New Zealand government – with OTMed NZ by your side,
you can rest assured, and ethically, do - what you do best …
With the Medsafe listed Hyper Medozon Comfort and Compact devices you
can
- Treat the listed indications.
- Use the listed modalities.
- Advertise that these services can be provided.