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全球 > 亚洲 >
New Zealand
市场信息
New Zealand’s healthcare expenditure was forecast to continuously increase between 2024 and 2028 by in total 5.6 billion U.S. dollars (+22.52 percent). After the sixth consecutive increasing year, the spending is estimated to reach 30.3 billion U.S. dollars and therefore a new peak in 2028.
Market Trend: According to the Financial Services Council (FSC), over 1.4 million or just under a third of people currently have health insurance in New Zealand
New Zealand’s medical equipment market revenue is expected to show an annual growth rate (CAGR 2023-2028) of 5.81%, resulting in a market volume of US$1,700.00m by 2028.
Within New Zealand, the oversight of medical device safety, quality control, and monitoring falls under the jurisdiction of the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). Medsafe's responsibilities encompass the regulation of medical devices in accordance with the Medicines Regulations 1984 and the Medicines Act 1981.
医疗器械法规
New Zealand Medicines and Medical Devices Safety Authority (Medsafe), under the MOH.
Regulation of medical devices done under the Medicines Regulations 1984 and its Medicines Act 1981.
分类、费用、时间表
DEVICE CLASS | FEES | TIMELINE |
|---|---|---|
Class I - Measuring | $575 | 4 weeks |
Class I - Sterile | $575 | 4 weeks |
AIMD | $1,370 | 6 months |
Class IIa | $1,098 | 4 weeks |
Class IIb | $1,098 | 6 weeks |
Class III | $1,416 | 6 months |
产品注册途径
DEVICE CLASS | DESCRIPTION |
|---|---|
Class I | Low risk (Measuring / Sterile) |
Class IIa | Low to moderate risk |
Class IIb | Moderate to high risk |
Class III | High risk |
AIMD | Active Implantable Medical Devices |
有用信息
许可证有效性：无有效期。
许可证转让：更换赞助商。
进口商和分销商：当地许可证持有人代表产品所有者负责指定进口商和分销商。
