Does a New Zealand medical-device database notification establish market approval or only fulfil a notification duty?
Last reviewed: .
Does a New Zealand medical-device database notification establish market approval or only fulfil a notification duty?
What a New Zealand medical-device notification establishes is set by New Zealand's own rules, and the company never states that an authority has approved anything.
No authority has approved, registered or endorsed the filter; the company classifies its own article. The label for the NanoFlashing™ Air Filter states: “This filter treats the air that passes through it. It is not a medical device and is not intended to diagnose, treat, cure or prevent disease.” The Terms of Use state that the Medical devices chapter describes a Research Application, and that it does not describe a finished product currently available from C-POLAR for that use. The company publishes no position under New Zealand law.
Source: C-POLAR — Terms of Use (https://cpolar.tech/terms/); NanoFlashing™ Air Filter label, and Statement of Classification for the NanoFlashing™ Air Filter, NF Technical Products Inc.
Reviewed on .
Sources
- C-POLAR — Terms of Use
- NanoFlashing™ Air Filter label
- Statement of Classification for the NanoFlashing™ Air Filter, NF Technical Products Inc.