How New Zealand Regulates Medical Devices After the Therapeutic Products Act

Current Legal Framework

New Zealand currently regulates medical devices under the Medicines Act 1981. Although the Therapeutic Products Act was passed in 2023, it was repealed in 2024 before it fully took effect. Because of this, the older legislative system continues to apply, and no new device approval pathway has replaced it yet.

Role of Medsafe

Oversight of medical devices sits with Medsafe, which operates within the Ministry of Health. Medsafe is responsible for market oversight, safety monitoring, incident management, and recalls. Rather than approving devices before sale, Medsafe relies on sponsor accountability and post-market controls to manage risk.

Market Entry and Device Notification

Medical devices supplied in New Zealand must be notified through the Web Assisted Notification of Devices (WAND) database. The local sponsor records details such as the device’s intended use, risk classification, and manufacturer. While this process does not involve formal approval, sponsors must hold evidence showing the device meets safety and performance expectations.

Risk Classification and Sponsor Duties

Devices are grouped by risk level, and higher-risk products may face closer regulatory attention. Sponsors are responsible for labeling, advertising compliance, and maintaining access to technical documentation. Medsafe may request this information at any time.