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Market Information

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.

Market Info

Medical Device Regulation

Taiwan Food and Drug Administration (TFDA), under the MOHW.

Regulation of medical devices done under the Medical Devices Act.

Classification, Fees, Timeline
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Product Registration Routes

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.

Useful Information

Validity of License: 5 years. (Renewal application must be submitted 10 months before the expiry date)


License transfer: Submit application form for change in medical device permit license.


Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.



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