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 for most devices.
Routes to approval vary based on classification, existing approvals in the US and European Union, and the existence of a predicate device in Taiwan. Class II and III devices require approval in the country of origin prior to registration in Taiwan. US- and EU-based manufacturers are eligible for a simplified quality system review process.
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 Regulatory Pathway report service for Taiwan covers topics including:
- TFDA Regulatory Background
- Product Assessment
- In-Country Representation in Taiwan
- Medical Device Registration Requirements
- Labeling and Language Requirements
- Costs and Timeframes
- Regulatory Roadmap for Taiwan
- Post-Market Obligations