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Taiwan Medical Device Registration Fees
TFDA government fees for 2025
TWD 15,000
Low Risk Min
TWD 250,000
High Risk Max
TFDA
Authority
2025-12-16
Last Updated
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
Registration - Class I | TWD 15,000 | Per registration |
Registration - Class II | TWD 58,000 | Per registration |
Registration - Class III | TWD 100,000 | Per registration |
Export Only All classes | TWD 15,000 | Per product |
Breakthrough Product First-in-world products | TWD 250,000 | Per product |
Priority Review (Expedited) | TWD 180,000 | Per registration |
Novel Product New mechanism/structure/material | TWD 130,000 | Per registration |
Important Notes
- •Standard registration by class
- •Special pathways for novel/breakthrough devices
- •Export-only devices have reduced fees
- •Priority review available for expedited processing
Frequently Asked Questions
Government fees are subject to change. Last data update: 2025-12-16. Always verify current fees with TFDA.