Medsafe, aka the New Zealand Medicines and Medical Devices Safety Authority, undertakes the regulation of therapeutic products in New Zealand. The Agency is a business unit of the Ministry of Health. It follows several legislations for regulating therapeutic products, the major ones being the Medicines Act of 1981 and Medicines Regulations. ‘Therapeutic purpose’ is described in the Medicines Act as the treatment, diagnosis, and prevention of disease or the modification of physiological activity.
Currently valued at $156 billion, the USA is the largest market for medical devices in the world representing approximately 40% of the global market. Given the scenario, manufacturers are on constant look out to market their products in the region. Enroute, even a small error in the approach can result a device recall. Therefore, it is necessary for the manufacturer to be at par with the latest regulations of USFDA (US Food and Drugs Administration) and chose the right Regulatory pathway that suits their device’s classification.