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Medical Device Product Registration and Approval in New Zealand

MEDICAL DEVICE REGULATION IN NEW ZEALAND

Medical devices are regulated by Medsafe (or New Zealand Medicines and Medical Devices Safety Authority) from the Ministry of Health whose objective is to enhance the health of New Zealanders by regulating medical devices to maximise safety and benefits. Medical devices are regulated under The Medicines Act 1981.

MEDICAL DEVICE REGISTRATION AND APPROVAL IN NEW ZEALAND

Medical devices are classified in the table below:

Source of table: Medsafe

Currently, no approval from Medsafe is needed for medical devices under the Medicines Act 1981 prior to being supplied in New Zealand. However, it is required for importers to notify Medsafe of the devices that are supplied here.

RESOURCES:

Guidance Documents:

• http://www.medsafe.govt.nz/regulatory/DevicesNew/industry.asp

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