Medical Device & Pharmaceutical Regulatory Consulting in Taiwan | GRP

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Medical Device and  Pharmaceuticals Regulatory Affairs and Quality Consulting for Taiwan

Taiwan Regulatory Affairs

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MARKET OVERVIEW

Taiwan produces and exports low-end devices and disposable products, therefore has a high demand for advanced medical supplies. Increasing levels of wealth amongst the population and a desire for improved living standards further boosts this demand. The Taiwanese market has growing potential for foreign medical device companies to expand their business, and is a desirable gateway for countries wishing to later enter larger Asian markets.

Taiwan Medical Device Market Size Taiwan Pharmaceutical Market Size
 $2 billion   $5.6 billion
Projected Growth Rate: 8%  Projected Growth Rate: 4%

 

Taiwan Economic Indicators
GDP (PPP): $1.1 trillion
Per Capita GDP (PPP): $47,000
Real GDP Growth Rate: 2.2%
Population (millions): 23.4
Ethnic Diversity: Taiwanese (including Hakka) 84%, Mainland Chinese 14%, indigenous 2%

REGULATORY AUTHORITY

The Ministry of Health and Welfare (MOHW)performs on-site inspection for local manufacturers and reviews Quality System Documentation (QSD) provided by foreign manufacturers.

Under the MOHW, the Taiwan Food and Drug Administration (TFDA)is Taiwan’s equivalent of the U.S. FDA. All imported medical devices must obtain a registration certificate from the TFDA. For more information of TFDA check website: http://www.fda.gov.tw/EN/