Medsafe (Medicines and Medical Devices Safety Authority) is the New Zealand government agency responsible for the regulation and management of medicines, medical devices and other medical products.Medsafe is responsible for evaluating and approving the registration of medical products, monitoring the quality, safety and efficacy of medical products, and supervising the production and distribution of medical products. Medsafe is responsible for assessing and approving the registration of medical products, regulating the quality, safety and efficacy of medical products, and overseeing their manufacture and distribution, etc. Medsafe's main task is to ensure that medical products available on the New Zealand market comply with national and international standards and requirements, and safeguard the health and safety of the public. To this end, Medsafe maintains close co-operation with other international pharmaceutical regulatory bodies to promote the safety and reliability of medical products.
If a medical device company has obtained CE marking from the European Union, FDA from the United States, or MDL/MDEL registration from Health Canada, it will need a local nominated sponsor (Sponsor) to list your product on MedSafe's WAND (Web Assisted Notification of Devices) database on MedSafe.
It is important to note that the local Sponsor is also licensed in New Zealand and is solely responsible and liable for the registration and listing of devices in New Zealand by foreign companies; is responsible for the accuracy of the information in the WAND and is the sole point of contact for Medsafe.