New Zealand medical device QA/RA blog

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Post ANZTPA, New Zealand Plans New Medical Device Regulatory System

The New Zealand government is in the midst of completely overhauling its regulatory system for medical devices following cancelled plans for a joint regulatory system with Australia.

New Zealand plans new medical device regulatory system in wake of ANZTPA cancellation.According to the New Zealand Ministry of Health, new legislation to replace the Medicines Act of 1981 will be introduced to the country’s parliament in 2016. The government plans a total “replacing and modernizing” of regulations covering drugs, medical devices and cell and tissue therapies.

The Ministry of Health has provided no details yet in terms of the substance of any new regulation, but states that New Zealand’s new regulations will align with international standards.

The latest news from New Zealand follows the nixing in late 2014 of plans made by the country’s Medicines and Medical Devices Safety Authority (MedSafe) and the Australian Therapeutic Goods Administration (TGA) to form a single regulatory entity, the Australia New Zealand Therapeutic Goods Agency or ANZTPA, to oversee both countries’ medical device markets. The ANZTPA project was abandoned due to concerns about costs and benefits as well as progress, according to MedSafe and the TGA.

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