REGULATORY ENVIRONMENT FOR MEDICAL DEVICES IN NEW ZEALAND
Journal Title: International Journal of Drug Regulatory Affairs - Year 2017, Vol 5, Issue 1
Abstract
Medical Devices are one of the most important health intervention tools available for the prevention, diagnosis and treatment of diseases and for patient rehabilitation. Although the Medical Devices market in the New Zealand region is very diverse, the existing regulations should be further developed to a greater extent for development of the country’s healthcare sector. Medsafe, the drug and medical device authority of New Zealand has taken steps towards this introducing a web-based online database however, only for the notification of devices in the market which means, there is no premarket assessment for all devices that get sold in the market. The notification process is comparatively very easy and the documentation that is prioritized by Medsafe is only the evidences of the device registration in other countries, like the FDA clearance, the CE certificate or the ARTG listing.
Authors and Affiliations
Akshay Anand M
Keywords
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- EP ID EP325751
- DOI 10.22270/ijdra.v5i1.191
- Views 140
- Downloads 0
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