Medsafe - New Zealand Medicine and Medical Devices Safety Authority

The Ministry of Health is the body within the government of New Zealand in charge of managing and developing the country’s health system. The ministry funds and monitors performance within the health sector and regulates it, ensuring all legislative requirements are being met. Within it, the New Zealand Medicine and Medical Devices Safety Authority is the unit responsible for regulating therapeutic products in the country.

Administering the Medicines Act 1981 and Regulations 1984, Medsafe regulates medicine, medical devices and other related products such as food or cosmetics with therapeutic uses. The authority is thus responsible for pre-marketing approval and post-marketing surveillance, such as monitoring adverse reactions, handling complaints as well as auditing and licensing medical manufacturers.

Major Regulations

Some of the most important regulations for medical devices in New Zealand are:

The list of Medsafe regulations can be found here.

Contact details: