| Regulatory Authority | Taiwan Food and Drug Administration |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, II, III |
| Medical Device Regulations | Guidance, Law & Regulations | Click Here |
| IVD Classification | I, II, III |
| Device Classification Guidelines | Regulations Governing the Classification of Medical Devices | Click Here |
| Registration Process | Medical Equipment Inspection Registration | Click Here |
| Registration Timeline | Around 12 months |
| Conformity Assessment Route |
https://www.fda.gov.tw/eng/siteList.aspx?sid=10333 |
| Technical Documentation Format |
Refer to Application for the Registration and Market Approval of Class 2 and 3 Medical Devices | Click Here |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in English and Chinese Language |
| Labeling Requirements |
Form for Affixing Medical Device Labels, Instructions, or Packaging | Click Here |
| Clinical Trials Information |
Information for Medical Device Clinical Trials | Click Here |
| Software Guidance Document |
Guidance for Industry on Management of Cybersecurity in Medical Devices(TFDA) | Click Here |
| Recalls |
Regulations for Medical Device Recalls | Click Here |
| Contact Phone | 886-2-2787-8000 |
| Contact Address | No.109, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City 115, Taiwan |