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Taiwan Medical Device Regulatory Strategy Report

Marketing your device in Taiwan requires approval from the Department of Health's Taiwan Food and Drug Administration (TFDA). In addition, quality system certification is also required prior to market authorization.

Let Emergo assist you in evaluating the Taiwanese medical device regulatory framework as it applies to your device(s)

Through our global network of in-house consultants as well as industry and regulatory contacts, Emergo provides incisive and accurate analysis of multiple medical device markets around the world, including Taiwan. Emergo's Global Regulatory Overview report service for Taiwan covers topics including:

  • TFDA Regulatory Background
  • Product Assessment
  • Authorized Representation in Taiwan
  • Medical Device Registration Requirements
  • Costs and Timeframes
  • Labeling and Language Requirements
  • Regulatory Roadmap for Taiwan

Please contact us for more information about our Regulatory Overview Report for Taiwan

Ask us for detailed information about Taiwan regulatory strategy services.

Learn about the process, costs and timelines.

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