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Medical device registration and approval in New Zealand - Emergo

    https://www.emergobyul.com/services/medsafe-medical-device-registration-new-zealand
    Although pre-market approval of medical devices is not necessary in New Zealand, market entry does require listing your product in MedSafe's Web Assisted Notification of Devices (WAND) database within 30 days of commercialization. Before your device is listed in WAND, you must ensure you have docum… See more

Medical Devices Home Page - Medsafe

    https://medsafe.govt.nz/devices/devices-landing.asp
    Information for Medical Device Suppliers. Medicines and Medical Devices Recall Code. Device Information. New Zealand Definitions. Medical Device Legislation. Overseas …

Regulatory Guidance for Medical Devices - Medsafe

    https://www.medsafe.govt.nz/regulatory/devicesnew/industry.asp
    Medical Devices Regulatory Guidance Policy Statements Medsafe's policy related to particular types of medical device. More... Importing Medical Devices into New Zealand …

Therapeutic products regulatory regime | Ministry of …

    https://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime
    Therapeutic products regulatory regime. We are working on a modern, comprehensive, cost effective regulatory regime for therapeutic products in New Zealand, …



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