New Zealand has a simple, one ethical committee, approval process that does not require U.S FDA Investigatory Device Exemption (IDE) filing prior to the start of a study.
Safety is paramount and the ethic committee will want to see pre-clinical data in animals, depending on the device.
Medical Device developers can gain the necessary in vivo information for investor and FDA submission decision making about their products quickly by collaborating with internationally recognized investigators.
New Zealand Legislation from Medsafe. Any New Zealand-based person or organisation that is manufacturing or importing medical devices for supply in New Zealand, or exporting medical devices will be required to enter details into a medical device database within 30 days of commencing supply or export of a new medical device.
WAND is a notification database only, and is reliant only on information provided by sponsors about their products. Inclusion of a notification on WAND does NOT indicate approval or any other endorsement of the device by Medsafe.
The Hon Peter Dutton MP, Minister for Health for Australia, and the Hon Dr Jonathan Coleman, Minister of Health for New Zealand, announced in November of 2014 their governments’ agreement to cease efforts to establish a joint therapeutic products regulator, the Australia New Zealand Therapeutic Products Agency (ANZTPA)
CE Mark is the regulatory approval that enables a company to sell its device in European countries. Obtaining the CE Mark means that the company is compliant with the European medical device directive that applies to the device.
Under an Agreement with the European Union, the New Zealand Designating Authorities are the Ministry of Health for Medical devices and human pharmaceuticals. The Medical Devices directive is administered by Medsafe – a division of the Ministry of Health. See more at: IANZ
510(k) clearance/ PMA approval are the regulatory routes that enable a medical device company to begin selling in the US. See FDA
510(k) clearance is the route the FDA applies the least amount of controls, making it the shortest and least demanding pathway. The core determination is proving the device is substantially equivalent to an existing device that has been cleared previously.
PMA approval is the process intended for high-risk devices. The most rigorous process, subject to the strictest controls and requires significant clinical data for hundreds of patients over a prolonged period.