TFDA current fee schedule, reviewed for 2026, in TWD.
24 fee lines100% exact amountscurrency TWDFX rates 2026-11-09reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Class I device registration (查驗登記) | TWD 15,000 | $457 | Per case | Verified |
| Class II device registration (查驗登記) | TWD 58,000 | $1,766 | Per case | Verified |
| Class III device registration (查驗登記) | TWD 100,000 | $3,044 | Per case | Verified |
| Export-only device registration | TWD 15,000 | $457 | Per case | Verified |
| Registration of new principle/structure/material/efficacy or no-predicate device | TWD 130,000 | $3,957 | Per case | Verified |
| Priority-review registration | TWD 180,000 | $5,479 | Per case | Verified |
| World-first no-predicate device requiring foreign-manufacturer audit | TWD 250,000 | $7,610 | Per case | Verified |
| Class I device filing (登錄) | TWD 10,000 | $304 | Per case | Verified |
| Annual declaration of filed devices | TWD 2,000 | $60.88 | Per year | Verified |
| Licence extension | TWD 8,000 | $244 | Per case | Verified |
| Filing-item change | TWD 8,000 | $244 | Per case | Verified |
| Change of efficacy/use/indication | TWD 40,000 | $1,218 | Per case | Verified |
| Change of specification | TWD 35,000 | $1,065 | Per case | Verified |
| Dimension/spec change not involving safety-efficiency assessment | TWD 25,000 | $761 | Per case | Verified |
| Transfer, merger, country-of-origin or plant-relocation change | TWD 25,000 | $761 | Per case | Verified |
| Other licence changes | TWD 10,000 | $304 | Per case | Verified |
| Licence reissue/exchange | TWD 1,500 | $45.66 | Per case | Verified |
| Foreign manufacturer QMS document review | TWD 60,000 | $1,826 | Per QMS application | Verified |
| Foreign QMS simplified low-risk review (Art. 78 reduced inspection) | TWD 30,000 | $913 | When eligible | Verified |
| Foreign on-site QMS inspection Plus TWD 35,000 (same building) / TWD 105,000 (different building) per additional plant, TWD 105,000 per additional sterilisation process, and TWD 300,000 per additional contract manufacturer. | TWD 600,000 | $18,264 | Per inspection | Verified |
| GDP inspection (including one warehouse) Plus TWD 10,000 per additional warehouse. | TWD 30,000 | $913 | Per inspection | Verified |
| Clinical trial plan review / report review | TWD 50,000 | $1,522 | Per review | Verified |
| Domestic GCP on-site inspection | TWD 45,000 | $1,370 | Per visit | Verified |
| Foreign GCP inspection | TWD 650,000 | $19,786 | Per country | Verified |
Government fees only — service and testing costs are separate- Registration and lifecycle fees follow the Medical Device Administrative Fee Standard (L0030123), amended 2023-02-23, effective 2023-03-01.
- Travel costs of foreign auditors are charged to the inspected firm (Art. 3).
- QMS review is manufacturer-level and is not a per-device registration fee.
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Exact amounts verified against the TFDA fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:taiwan:class-i-registration