The Taiwan agent rule
Foreign manufacturers file through a Taiwan agent — the official face to the TFDA, with post-market duties.
Free field guide · PDF
Taiwan TFDA Medical Device Registration2026 Field Guide
The Taiwan agent rule, QSD timelines, and the predicate-device shortcut — with the 5-year licence reality.
- Licence validity
- 5 yrs
- Class II timeline
- 8–12 mo
- Class II fee
- NT$60K
Sourced from TFDA 2026 registration guidance and practice.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — TFDA 2026 registration guidance and practice.
The parallel QSD track
QSD review takes 6–8 months and runs concurrently with the device application — with an expedited TCP III pathway.
The predicate shortcut
Acceptable predicates mean quicker review, lower fees, and reference-market exemptions from local clinical data.
Sources & scope
- elendilabs.com, Taiwan medical device registration: local agent, classification, QSD.
- thema-med.com, medical device registration in Taiwan.
- fda.gov.tw, FAQs regarding registration of medical devices.
- asiaactual.com, identifying predicate devices in Asian countries.
This guide is market-access intelligence, not regulatory or legal advice. TFDA timelines, fees, and QSD requirements are product-specific — professional review is required before business use.
Market Access Strategy Session
Taiwan on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your TFDA route — agent selection, QSD sequencing, and the predicate-device plan.
Professional review is required before business use.
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