Medical Device Registration and Approval in Taiwan

General country-specific regulatory information is provided on this page for medical device registration and approval in Taiwan. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Taiwan, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Taiwan

 REGULATORY AUTHORITY: Medical devices are regulated by the Taiwan Department of Health (DOH).

CLASSIFICATION SYSTEM: Medical 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 Taiwan medical device 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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