Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. It is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand.
Medsafe regulates products used for a therapeutic purpose. These include:
* related products
* medical devices
* controlled drugs used as medicines
Medsafe is responsible for applying a framework of controls designed to ensure that the therapeutic products available in New Zealand are those that can be expected to have greater benefits than risks if used appropriately. This is achieved through:
* pre-marketing approval of products
* post-marketing surveillance.
The DTS team can co ordinate your product development activities and submissions to meet NZ regulatory requirements..