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Medical Devices / Regulatory Affairs

Taiwan FDA Drafts First Medical Devices Act, Separating Drugs From Devices

July 14, 2017

The Taiwan Food and Drug Administration is starting the process of drafting separate medical device regulations for the first time.

The Taiwan FDA said that as other countries have developed laws and regulations specifically for regulating medical devices, it was time the country developed regulations covering the management of devices.

Medical devices are currently regulated in Taiwan under the Pharmaceutical Affairs Act, which was enacted in 1993.

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