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Any item that is meant to be used in, on, or for humans for a therapeutic purpose and (ii) does not accomplish its primary intended action in, on, or on the human body via pharmacological, immunological, or metabolic mechanisms is considered a medical device.
A risk to the human body-based classification system is used in New Zealand. Classes I (self-certified, sterile, or measuring), IIa, IIb, III, and AIMD are ranked in order of increasing risk. In New Zealand, classification is done according to a set of rules.
Since this approach closely resembles the EU and Australian models, most classifications made using it will be applicable in the EU.
Medical device pre-market approval is not required in New Zealand, but in order to enter the market, your product must be listed in MedSafe’s Web Assisted Notification of Devices (WAND) database within 30 days after commercialization.
You must make sure you have proof of your device’s effectiveness and safety before it is listed in WAND because MedSafe may need this information. Examples of such proof include certification from an EU Notified Body, Health Canada, or the US FDA.
New Zealand medical devices market accounted for $XX Billion in 2023 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.
After obtaining further initial funding, New Zealand-based health tech firm Webtools Health has separated its cloud-based connected care platform Centrik.
New Zealand’s Webtools Health introduces a connected care platform.Centrik is a digital platform that connects the health ecosystem and has many components. With the help of PatientEx, its most recent module, users can sign up, access records, and engage with clinical professionals.
Another element, ProviderEx, provides medical professionals with a cutting-edge web-based interface that can be accessed from any device, as well as multi-factor authentication, role-based access controls, and automatic digital engagement via customizable forms and assessments.
Finally, thanks to its SolutionCentre module, providers may quickly create, modify, and deploy the system.
The system’s consumer-facing features will be made available through a single mobile application called Better Health Outcomes, including a patient portal (which allows for two-way communication with the provider), check-in capabilities, patient messaging and notifications, as well as payments.
Later on, the platform will make it possible to communicate with remote monitoring systems and let patients exchange medical records.
