市场信息
Taiwan’s healthcare expenditure was approximately 6.6% of its Gross Domestic Product (GDP) in January 2022.
Market Trend: In March 1995, the Taiwanese government implemented the national health insurance (NHI) system, which replaced various separate insurance schemes that covered approximately 57% of the population prior to its introduction.
Taiwan’s medical equipment market stands as a significant market for U.S. medical device exports, being positioned within the top 25 globally in terms of value. By 2019, Taiwan's medical device market had expanded to around $4.2 billion, constituting about 5.4% of the entire healthcare expenditure in the country.
The inception of the Taiwan Food and Drug Administration (TFDA) occurred on January 1, 2010, subsequent to the passing of the TFDA Organization Act on June 3, 2009. This act amalgamated several bureaus, including the Bureau of Food Safety, the Bureau of Pharmaceutical Affairs, the Bureau of Food and Drug Analysis, and the Bureau of Controlled Drugs into the TFDA.
Following the enforcement of the Organic Act of the Ministry of Health and Welfare in July 2013, the Taiwan Food and Drug Administration (TFDA) became a component of the newly established Ministry of Health and Welfare.
医疗器械监管
Taiwan Food and Drug Administration (TFDA), under the MOHW.
https://www.fda.gov.tw/eng/siteList.aspx?sid=10333
Regulation of medical devices done under the Medical Devices Act.
分类、费用、时间表

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产品注册途径
Class I, II, III, IV
Standard Mode
Simplified Mode
Priority Review
For Class II (NT$15,000) and III (NT$30,000).
Expedites reviews by 1-2 months.
有用信息
许可证有效期:5年。(续期申请须在有效期届满前10个月提交)
许可证变更:提交医疗器械许可证变更申请表。
进口商和分销商:本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。
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