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: Medical devices are regulated by the Taiwan Department of Health (DOH).
Devices are classified according to risk into Class I, II and III, with Class I being the lowest risk and III the highest. New medical devices – those without an equivalent previously approved by the DOH – are placed into a separate category.
First, Quality System Documentation (QSD) approval is required, which can take three to four months. The product registration process takes an additional seven to nine months.
Licenses issued in Taiwan are valid for five years.
A local representative is required.
Last updated on February 9 2015.
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