: 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. TIMEFRAME:
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. LICENSE VALIDITY:
Licenses issued in Taiwan are valid for five years. AUTHORIZED REPRESENTATIVE:
A local representative is required.
Last updated on February 9 2015.
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