Things You Should Know About Medical Device Registration in New Zealand

OTMed NZ Medozon devices are notified to the Medsafe WAND database as required under the Medicines (Database of Medical Devices) Regulations 2003. Before a device can be listed on WAND, the sponsor must be able to provide Medsafe with documentation demonstrating the device's safety and performance — such as CE certification from a recognised European Notified Body.
It is important to understand that WAND notification is a mandatory legal requirement for any medical device supplied in New Zealand — it is not a product approval or endorsement by Medsafe. Medsafe does not currently operate a pre-market approval system for medical devices.
HAB Herrmann Medozon devices hold CE certification as Class IIb medical devices under European medical device directives, and are manufactured to ISO 9001, ISO 14001 and OHSAS 18001 standards. This European certification is the basis for WAND notification in New Zealand.
Practitioners using ozone-oxygen therapy devices in New Zealand must comply with all applicable New Zealand regulations, including their obligations under the Health Practitioners Competence Assurance Act 2003, the Medicines Act 1981, and the Fair Trading Act 1986. Any advertising of therapeutic services must be accurate, substantiated, and not misleading.

For more information on the WAND notification system, visit medsafe.govt.nz.