Medical Device Regulatory Requirements in Taiwan
| 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 |
| Registration Process |
Medical Equipment Inspection Registration
| Click Here
|
| Registration Timeline |
Around 12 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in English and Chinese Language |
| Adverse Event Reporting Form |
Download |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025