Taiwan Blog Posts

Taiwan’s “Two-Step” Medical Device Review Program Launch Imminent

Taiwanese medical device market regulators are launching their new “two-step” review program on November 10, 2015, after which administrative and technical device reviews will no longer be conducted in parallel.

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Substantial Medical Device Review Fee Increases at Taiwan Food and Drug Administration

Taiwan’s medical device market regulator has published significant new fee increases for various aspects of their device review and approval process. The increases are set to take effect July 1, 2015.

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Major Changes Set for Taiwan’s Medical Device Registration Process

The Taiwan Food and Drug Administration (TFDA) plans to implement significant changes to its registration and approval system for medical devices, according to Emergo consultants in Taipei.

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Medical Device Sector in Taiwan Primed for Seven-Percent Growth

A new study by the Taiwan Industry of Economic Affairs’ Industry and Technology Intelligence Services (ITIS) projects the country’s medical device industry to grow to $2.71 billion in 2013, an increase of more than seven percent.

According to the ITIS and BioSpectrum, the increase in Taiwain’s medical device sector will be driven primarily by demand for contact lenses and blood glucose monitors in the country. These two products will buy the entire medical device sector despite a nearly seven-percent decline between Q4 2012 and Q1 2013. The IT IS expects medical device sector growth of nearly 17% from Q1 to Q2 2013.

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